Aim: To explore the causes of the difference in spermatogenic suppression between responders and non-responders in Chinese men treated with levonorgestrel (LNG) implants plus testosterone undecanoate (TU) injectable. ...Aim: To explore the causes of the difference in spermatogenic suppression between responders and non-responders in Chinese men treated with levonorgestrel (LNG) implants plus testosterone undecanoate (TU) injectable. Methods: The 16 Chinese volunteers treated were divided into two groups in regard to the sperm count during the treatment period, 7 men in the responder group (Group R), including 6 azoospermia and one severe oligozoospermia, and the remaining 9 in the non-responder group (Group N), including 4 oligozoospermia and 5 with sperm counts greater than 20×106/mL. The differences in serum profiles of FSH, LH, T, LNG and T/LH ratio were compared between the two groups and the correlation between the seminal fluid parameters and serum reproductive hormones was analyzed. Results: The serum FSH level was lower in Group R than that in Group N (P<0.05), while the serum LH and LNG levels were higher in Group R than those in Group N (P<0.05). The sperm density (P<0.01, r=0.235), motility (P<0.01, r=0.326) and vitality (P<0.01, r=0.219) showed significantly positive correlation with the serum FSH level. Conclusion: The blood LNG and T levels, the degree of FSH inhibition and/or the sensitivity of the pituitary-testis axis to exogenous steroids, as well as the individual spermatogenetic potential and the functional status of the Leydig cells may be factors bringing about individual differences in spermatogenic suppression in Chinese men treated with LNG and TU.展开更多
Objective: To compare the efficacy and side effects of levonorgestrel and low dose mifepristone in emergency contraception. Method: The study is a randomized double--blind multicenter comparative trial. A total of 1, ...Objective: To compare the efficacy and side effects of levonorgestrel and low dose mifepristone in emergency contraception. Method: The study is a randomized double--blind multicenter comparative trial. A total of 1, 276 women with unprotected intercourse within 72 hours were allocated to one of the two study groups. In the levonorgestrel (LNG) group, 0. 75 mg LNG was taken twice, 12 hours apart, whereas in the mifepristone (Mife) group, a single dose of 10 mg mifepristone was taken and a placebo 12 hours after. Follow--up visit was paid on the seventh day of the expected next menstruation to evaluate the contraceptive efficacy and side effects. Contraceptive efficacy was calculated by Dixon’s method. Result:In the LNG group 20 pregnancies occurred among 643 women, while in the Mife group 9 pregnancies occurred among 633 women. The pregnancy rates were 3. 10% and 1. 43% respectively. Contraceptive efficacy rate of preventing pregnancy was 59. 16% and 79. 73%, the difference was statistically significant (P<O. 05). The incidence of various side effects, which were mild, was less than 10%. There was no statistical difference between the two groups. The percentage of subjects who had their next menstruation 3 days earlier or later than their expected menstruation in LNG group and Mife group was 77. 7% and 78. 5% respectively. Conclusion: Use of levonorgestrel or low dose mifepristone for emergency contraception is effective and safe.展开更多
Objective To investigate possible causes resulting in the differences in the spermatogenesis suppression on individual treated with levonorgestrel (LNG) implants and testosterone undecanoate (TU) injectableMethods Tot...Objective To investigate possible causes resulting in the differences in the spermatogenesis suppression on individual treated with levonorgestrel (LNG) implants and testosterone undecanoate (TU) injectableMethods Totally 21 Chinese male volunteers were given treatment with LNG implants (four rods, 75 mg/rod) and intramuscular injection of TU (500 mg,bimonthly for 3 times). According to the effects of treatment, they were divided into two groups, namely, azoospermia group (group A) and oligozoospermia group (group O). Then seminal FSH, LH, T and estradiol (E2) were determined by immunoenzymetric assay, while seminal and serum dihydrotachysterol (DHT) and serum sex hormone binding globulin (SHBG) were by radioimmunoassay, and seminal transferrin (Tf) by scatter turbidimetry assay.Results Seminal FSH, LH and serum DHT, SHBG, FTI (T/SHBG ×100) levels were significantly lower in group A than in group O, while higher seminal concentrations ofE2 were observed in azoospermia group.Conclusion The differences in the spermatogenic suppression in Chinese men might be attributed to different rate of peripheral androgen metabolism, variations in serum SHBG levels, 5á-reductase activity and individual aromatase activity during LNG plus TU administration. In addition, seminal sex hormones might be more sensitive indexes to assess the extent of feedback inhibition on hypothalamus-pituitary-testis with exogenous testosterone plus progestogen in the efficacy hormone male contraceptive trials.展开更多
In this study,a new class of biodegradable contraceptive implants was prepared via the UV irradiation molding method,among which,progestin levonorgestrel(LNG)was used as a model drug.Photo-cross-linked aliphatic polyc...In this study,a new class of biodegradable contraceptive implants was prepared via the UV irradiation molding method,among which,progestin levonorgestrel(LNG)was used as a model drug.Photo-cross-linked aliphatic polycarbonates(APCs),namely,poly(trimethylene carbonate-co-2,2′-dimethyltrimethylene carbonate)[P(TMC-co-DTC)]elastomers,were used as the drug delivery matrix.The results obtained from the degradation experiments carried out in Sprague-Dawley(SD)rats showed that the cross-linked elastomer had the degradation characteristics of the surface erosion degradation mechanism,with no generation of acid degradation products,and excellent form-stability,which met the performance requirements of the matrix for a long-acting sustained-release delivery system.The in vitro cytotoxicity tests and histological and immunohistochemical evaluations showed good biocompatibility and biosafety of the elastomer matrix material and contraceptive implants.Subsequently,the implant formulations were screened by in vitro release experiments,and their release kinetics were explored.Finally,in the evaluation study of the in vivo anti-fertility effect,the implants exhibited excellent dimensional stability and were degraded by a surface erosion mechanism.LNG achieved a stable and sustained release in female SD rats,maintaining a long-acting contraceptive duration of up to 4 months.The contraceptive implants obtained in this study could be used to address the limitations of currently available formulations,which required secondary surgical removal and a single means of regulating drug release kinetics.Therefore,these implants could provide a new option for birth control needs and may be of significance in reducing the incidence of induced abortion and protecting female fertility.展开更多
Introduction: Contraceptive implants are one of the most effective methods of birth spacing. Jadelle<sup>®</sup> implants consist of two strands that are easy to insert and remove. Although their e...Introduction: Contraceptive implants are one of the most effective methods of birth spacing. Jadelle<sup>®</sup> implants consist of two strands that are easy to insert and remove. Although their effectiveness is no longer in question, their use (insertion) requires a surgical procedure with the corollary possibility of complications. These are mainly insertions that are too deep (in the arm muscle), vascular and nerve damage. Material and Methods: Our study focused on complications related to implant insertion. It was a descriptive and retrospective study over thirty-four months, from October 2016 to July 2019, and concerned all patients seen in consultation and who presented a complication related to the insertion of contraceptive implants in the Department of Gynecology and Obstetrics of the National Hospital of Pikine. Results: We collected nine complications managed at the Gynecology and Obstetrics Department of the Centre Hospitalier National de Pikine from 2016 to 2019. These were insertions that were too deep with sometimes nerve damage, infection or incident during anesthesia. The operative procedures were based on the type of complication. Conclusion: Although Jadelle<sup>®</sup> has the advantage of having only 2 rods compared to its predecessor Norplant<sup>®</sup>, its use is also conditioned by insertion and removal procedures which may experience complications.展开更多
Objective: To compare the efficacy, side-effects and acceptability of domestic produced implant No. I and No. II with Norplant. Method: A multicentered randomized prospective clinical trial was conducted in ten center...Objective: To compare the efficacy, side-effects and acceptability of domestic produced implant No. I and No. II with Norplant. Method: A multicentered randomized prospective clinical trial was conducted in ten centers in Chi na since 1993. Every center have recruited 100 cases for each of the three types of implants. Results: Altogether l, 001 cases of No. I, 1, 000 cases of No. II and 998 cases of Norplant were recruited. The follow--up rate was 99. 2% at the end of 24 months and 99. 1% at the end of 36 months. One pregnancy in No. I implant occurred & months after insertion and the net cumulative pregnancy rate was 0. 1 per 100 women. Total discontinuation rates were 15. 1, 14. 1, and 12. 9 per 100 women in NO. I, No. II and Norplant groups respectively. Among them about 75% of discontinuation was due to the menstrual problems. The incidence of side-effects were 22. 6%, 19. 0% and 19. 7% respectively at 36 months follow--up. There was no significant differences in efficacy and side effects among these three types of implant. Conclusion: The result of this three-years’ follow--up indicated that the domestic products implant No. I and No. II just as Norplant are long term, highly effective contraceptive and have been accepted in different area by different people. It will be widely selected by women of reproductive age in China.展开更多
CaproF is a biodegradable subcutaneous contraceptive implant of releasing levonorgestrel (LNG), which is expected to provide an effective contraception for 2 years. This study was undertaken to assess the one year pr...CaproF is a biodegradable subcutaneous contraceptive implant of releasing levonorgestrel (LNG), which is expected to provide an effective contraception for 2 years. This study was undertaken to assess the one year preliminary clinical results of using CaproF in 19 subjects. All subjects (n=19) completed the 1 year study, and the contraceptive effectiveness and follow up rate were both 100%. The incidence of side effects was low. The major side effects were menstrual disorder, but bleeding patterns tended to be improved and restored to be the same as pre implantation ones with time. There were no significant increase in weight (P>0.05) and no changes in blood pressure. In the 3 rd , 6 th and 12 th months after using CaproF, the cervical mucus became scanty and viscous without fern like crystals. The amount of menstrual blood loss decreased from 49.38 ml of pre implantation to 33.23 ml of the 12 th month of using the implant (P<0.05). Hemoglobin concentrations showed no changes, but serum ferritin concentrations were slightly increased. No changes in liver function, kidney function, glucose tolerance test and lipoprotein levels were found. Determinations of sex hormones (FSH, LH, E 2 and progesterone) levels, ultrasonography of ovary, and endometrial biopsy in observed group (n=9) showed that all had normal ovulation before insertion. But ovulation was suppressed and endometrium development was inhibited after insertion. All basal body temperatures were single phase patterns during the 1 year follow up. This study suggested that CaproF is an effective, safe and acceptable long acting contraceptive method. It is likely to reach its contraceptive effectiveness through suppressing ovulation, inhibiting endometrium development and influencing cervical mucus characteristics.展开更多
Objective To evaluate the prevalence of functional ovarian cysts in users of two different types of contraceptive implants. Methods A total of 239 women were enrolled at 3 months of use of the etonogestrelreleasing ...Objective To evaluate the prevalence of functional ovarian cysts in users of two different types of contraceptive implants. Methods A total of 239 women were enrolled at 3 months of use of the etonogestrelreleasing implant (Implanon) and the levonorgestrel-releasing implant (Jadelle). Bimanual pelvic examination and vaginal ultrasound were performed during routine 3, 6 and 12-month visits of asymptomatic women(control group). Women with ovarian cysts (or enlarged ovarian follicles 〉25 mm) (cysts group) were assessed weekly until disappearence or reduction of the image (including estradiol (E2) and progesterone measurement and women with no ovarian enlargement underwent same evaluation for the same period of time. Results Ovarian cysts were detected in 5.1% and 13.0% of users of Implanon and Jadelle, respectively, at 3rd month. At the 6th month of use, prevalences were 7.1% and 7.8%, and at 12th month rates were 25.7% and 14.7% in the two groups, respectively. E2 levels were significantly higher in cysts group than in control group. The time until disappearance of the ovarian cyst was similar in Implanon and Jadelle group. There were more cases of menorrhagia in patients rveth ovarian cysts than in patients with no ovarian enlargement. Conclusions The finding of ovarian cysts or enlarged ovarian follicles during the first year of use of Implanon and Jadelle implants is common and transient and should not be interpreted as a pathologic ovarian cyst. No further medical interventions are necessary.展开更多
A multicentre comparative clinical study of CLa implant and Sino-implant was carried out at 100 subcentres in 11 provinces, and α total of 19673 subjects were recruited. Two-year follow-up has been finished. The foll...A multicentre comparative clinical study of CLa implant and Sino-implant was carried out at 100 subcentres in 11 provinces, and α total of 19673 subjects were recruited. Two-year follow-up has been finished. The follow-up rate at the end of two years was 94.29%. Two-year cumulative continuation rate per 100 women for Sino-implant(89.93) was significantly higher than that for CLa implant (88.89). Two-year cumulative pregnancy rates per 100 women were 0.0462(CLa implant) and 0.281(Sino-implant) respectively, there was statistically significant difference between them. No ectopic pregnancy was recorded among CLa implant users and three ectopic pregnancies were reported among Sino-implant users,resulting in an ectopic pregnancy rate of 0.163 per 1000 women-years. The incidence of side effects appeared to diminish with time. The major side-effects were the menstrual disturbances, which accounted for more than 90% of the total sideeffects, and the incidence of frequent menstruation, irregular bleeding and spotting was higher than that of infrequent/scanty menstruation and amenorrhea. Use of CLa implant had higher incidence of amenorrhea and infrequent/scanty menstruation than that of Sino-implant. During two-year follow-up, the number of discontinuation due to menstrual problems contributed 78% of the total number of discontinuation; two year menstrual-related cumulative discontinuation rates were 8.96 per 100 women for CLa implant and 7.84 for Sino-implant, there wasAddress coryespoll(lol,c'c toe D]' Fang ac juan, Shanghai Institute of Planned Pal.cnthood Research, 2140 Xit, 'I'u BOilal. Shanghai. 200032, China. Tel/F..f 86--021 64171432 E ..ill SIPPRms. STN. sh. C Nstatistically significant difference(P< 0.01). Two year study shows that the two types of implant are similar to Norplant in the incidence of side-effects and contraceptive efficacy as well as two year continuation rates.展开更多
Unintended pregnancy rates remain high throughout the World and increase the risk of poor maternal and infant outcomes.Most of unintended pregnancies occur in women who were not using contraceptionor who became pregna...Unintended pregnancy rates remain high throughout the World and increase the risk of poor maternal and infant outcomes.Most of unintended pregnancies occur in women who were not using contraceptionor who became pregnant despite the reported use of contraception.Women who have had recent unprotected intercourse including those who have had another form of contraception fail are potential candidates for this intervention.Currently used em-ergency contraceptive methods are pills that contain combined estrogen-progesterone,only progestin,antiprogestins and copper intrauterine devices.The most common form of this type of contraception is oral progestin-only pills(levonorgestrel).The most effective method is copper intrauterine devices followed by anti-progestins and oral progestin-only pills.The major pathogenesis of oral emergency contraceptives is the prevention or delay of ovulation.Although conception is possible on only a few days of the cycle,emergency contraception is offered when indicated without regard to the timing of the menstrual cycle because of uncertainty in the timing of the ovulation.Levonorgestrel and E/P regimes are most effective as soon as possible after unprotected sexual intercourse.A linear relationship has been shown between ef-fectiveness and the time of dose.The effectiveness continues for 120 h,but it is recommended to be used within 72 h after intercourse.Intrauterine devices may prevent pregnancy when 5 d after ovulation.展开更多
Objective: To assess levonorgestrel-releasing intrauterine system LNG-IUS (Mirena?) application at caesarean section (CS). Design: Randomized, comparative study. Setting: Department of obstetrics and gynecology in a p...Objective: To assess levonorgestrel-releasing intrauterine system LNG-IUS (Mirena?) application at caesarean section (CS). Design: Randomized, comparative study. Setting: Department of obstetrics and gynecology in a primary reference hospital at Puebla City, Mexico. Sample: 396 women requiring CS signed informed consent and were randomly allocated to the post-placental application of LNG-IUS (198) or Copper T 380 A (198). Methods: Follow up visits at 6 weeks, and 6 and 12 months were performed. Main Outcomes Measures: IUDs expulsion, maternal and babies’ health conditions, breastfeeding and menstrual patterns, adverse effects and pregnancies. Differences between groups were analyzed by Fisher and X2 tests, Odds ratios, relative risk and 95% confidence limits, as appropriate. Results: After one year of follow up, no pregnancies were reported. The IUD expulsion rate was 4.5% in each group. LNG-IUS users had a higher incidence of amenorrhea (OR 2.5 95% CI 2.2 - 3) and menstrual patterns significantly brief and lighter than Copper T 380 A (p < 0.001) with lower incidence of dysmenorrhea (OR 0.1 95% CI 0.04 - 0.2). No detrimental effects of LNG-IUS on breastfeeding was observed and interestingly babies weights of LNG-IUS users was slightly above the average for age compared with Copper T 380 A users. This was probably related with a major proportion of women with normal ferritin serum levels (94% vs 68%) leading to better mother’s general condition. Conclusions: LNG-IUS inserted during CS provides high efficacy contraception with additional benefits, mainly reducing menstrual bleeding and doing so, faster recovery of ferrous homeostasis after CS.展开更多
Objective To develop a new contraceptive implant containing gestodene featuring with only one rod for 5 years long effectiveness and safety. Methods Gestodene synthesis, polymer tube designatiou, in vitro or in vivo t...Objective To develop a new contraceptive implant containing gestodene featuring with only one rod for 5 years long effectiveness and safety. Methods Gestodene synthesis, polymer tube designatiou, in vitro or in vivo test, the pilot test was used for the establishing of minimum clinic dosage. Results It had a burst effect at beginning and become constantly releasing since 12th day. It had zero-order releasing, in vitro, the average releasing rate was 17.0-19.1μg/d, the safe dosage was 70.2mg/kg, C1hr. was 2.91 ± 1.25 ng/ml, Tmax was 8.86± 4.32 h, C was 7.31 ± 1.09 ng/ml, Tss was 14 d, Css was 4.16 ±0.48 ng/ml. Twenty-four hours later after removal of the implant, gestodene was ahnost cleaned out in the blood circulation and only trace amount of drug was detected after the removal. Conclusion One rod gestodene implant is a new tong effective contraceptive and may be promising.展开更多
Objective: To document our experience on the use of Jadelle/Implanon contraceptives that was recently introduced into Ahmadu Bello University Teaching Hospital (ABUTH), Zaria, Nigeria. It is pertinent to generate data...Objective: To document our experience on the use of Jadelle/Implanon contraceptives that was recently introduced into Ahmadu Bello University Teaching Hospital (ABUTH), Zaria, Nigeria. It is pertinent to generate data on the experiences in the use of this contraceptive in a cross sectional study within Zaria, Northern Nigeria. Method: Data on consecutive clients that accepted Jadelle/ Implanon from June 2009 to November 2013 at ABUTH were extracted from their cards and analyzed using SPSS version 17. Out of a total of 11,502 clients that were for contraception during the period under review, 798 accepted Jadelle/Implanon accounting for 7% of the total clients. All the clients were married. About 67.8% were Muslims while 27.2% were Christians and 5% belong to other sect. 4140 (36%) had tertiary education. Most of the client has been on one form of modern contraception;only 16% were first time users who accepted implant after counselling. 37% of the?clients are full time housewives. The discontinuation rate was found to be 26% for Jadelle and 19%?for Implanon. No pregnancy was recorded during this period. Conclusion: Jadelle/Implanon account for 7% of contractive uptake and a high discontinuation rate was found among the users.展开更多
This review summarizes the drugs and chemicals that may modulate embryo implantation.Non-hormonal molecules,including aspirin,improved endometrial blood flow,while low molecular weight heparin,vitamin E,sildenafil,and...This review summarizes the drugs and chemicals that may modulate embryo implantation.Non-hormonal molecules,including aspirin,improved endometrial blood flow,while low molecular weight heparin,vitamin E,sildenafil,and atosiban modulated the expression of endometrial genes.Hormonal factors,including human chorionic gonadotropin and growth hormones,can regulate the expression of endometrial receptivity markers.Other immunomodulatory molecules,including granulocyte colony-stimulating factor,peripheral blood mononuclear cells,autologous platelet-rich plasma,and intralipid and intravenous immunoglobulins,may improve implantation rate by modulating endometrial immune functions.Medicinal extracts of the Chinese herbs Paeonia lactiflora and Perilla frutescens increased the expression of leukemia inhibitory factors in endometrial epithelial cells.Recently,the use of the commercially available Library of Pharmacologically Active Compounds with a high-throughput screening method has provided an approach to screen for compounds that may potentially enhance or suppress embryo implantation.Whether these biomedical findings translate into clinical effects that enhance or suppress embryo implantation requires further investigation.展开更多
The purpose of this study was to use a kind of safe,long acting and reversible hormonal regimen for male contraception .The studied regimen was a subdermal insertion of a two rod implant (Sino implant, each rod c...The purpose of this study was to use a kind of safe,long acting and reversible hormonal regimen for male contraception .The studied regimen was a subdermal insertion of a two rod implant (Sino implant, each rod containing 75 mg levenorgestrel LNG) in each subject's forearm, followed 3 weeks after by monthly injection of TU (Testosterone Undecanoate 250 mg) for 3 months. Eighteen weeks after implantation, the Sino implant was removed. There were altogether 16 male volunteers recruited in the entire research program. Among them 6 cases reached azoospermia; one case reached oligozoospermia (sperm density <3 million/ml); 5 cases' sperm density declined greatly, the lowest to be 5.7±1.3 million/ml; the other four cases' sperm density also declined, but remained within normal range (above 20 million/ml), the lowest to be 24.5±9.0 million/ml. The duration to reach azoospermia was 16.7±0.5 weeks. The duration to resume to normal range of sperm density was 8.2±2.5 weeks in the subjects with azoospermia and oligozoospermia. In the first two weeks after insertion the LNG release of Sino implant's mean serum LNG level was about 0.38 ng/ml, in the rest of the time the LNG levels in blood was rather constant about 0.24 ng/ml. Routine analyses of blood and urine, liver and kidney functions, and blood chemistry including those parameters (TG,TC,HDL C,LDL C) of lipid metabolism didn't change much throughout the research. All the subjects' libido and sex function were well kept. Clinical observation didn't show any other adverse effects during the research.展开更多
We have investigated the feasibility of administration of testosterone undecanoate (TU)-Ioaded injectable in situ-forming implant (ISFI) for contraception in adult male Sprague-Dawley rats. Male rats were treated ...We have investigated the feasibility of administration of testosterone undecanoate (TU)-Ioaded injectable in situ-forming implant (ISFI) for contraception in adult male Sprague-Dawley rats. Male rats were treated with vehicle, TU-Ioaded ISFIs (540, 270 and 135 mg TU kg-1) or TU injections (45 mg TU kg-1 every 30 days) for 120 days. Fertility tests served for determining infertility or restoration of fertility in treated rats. Serum testosterone concentration, epididymal sperm count, motility, morphology, and histology of the testis were monitored. The TU-Ioaded ISFIs increased serum testosterone levels in rats steadily without fluctuation over 3 months. One month after TU administration, the epididymal sperm count decreased significantly in all experimental groups. After 3 months, the animals treated with 270 and 135 mg kg-~ TU-Ioaded ISFIs were 100% infertile, and no implantation sites were produced in the mated females. However, some of males treated with 540 mg kg-~ ISFI or TU injections were still fertile but numbers of implantation sites were also significantly lower than control values. TU-Ioaded ISFI at an appropriate dose has potential as a long-acting male contraceptive drug that suppresses spermatogenesis consistently over a period of 3 months.展开更多
文摘Aim: To explore the causes of the difference in spermatogenic suppression between responders and non-responders in Chinese men treated with levonorgestrel (LNG) implants plus testosterone undecanoate (TU) injectable. Methods: The 16 Chinese volunteers treated were divided into two groups in regard to the sperm count during the treatment period, 7 men in the responder group (Group R), including 6 azoospermia and one severe oligozoospermia, and the remaining 9 in the non-responder group (Group N), including 4 oligozoospermia and 5 with sperm counts greater than 20×106/mL. The differences in serum profiles of FSH, LH, T, LNG and T/LH ratio were compared between the two groups and the correlation between the seminal fluid parameters and serum reproductive hormones was analyzed. Results: The serum FSH level was lower in Group R than that in Group N (P<0.05), while the serum LH and LNG levels were higher in Group R than those in Group N (P<0.05). The sperm density (P<0.01, r=0.235), motility (P<0.01, r=0.326) and vitality (P<0.01, r=0.219) showed significantly positive correlation with the serum FSH level. Conclusion: The blood LNG and T levels, the degree of FSH inhibition and/or the sensitivity of the pituitary-testis axis to exogenous steroids, as well as the individual spermatogenetic potential and the functional status of the Leydig cells may be factors bringing about individual differences in spermatogenic suppression in Chinese men treated with LNG and TU.
文摘Objective: To compare the efficacy and side effects of levonorgestrel and low dose mifepristone in emergency contraception. Method: The study is a randomized double--blind multicenter comparative trial. A total of 1, 276 women with unprotected intercourse within 72 hours were allocated to one of the two study groups. In the levonorgestrel (LNG) group, 0. 75 mg LNG was taken twice, 12 hours apart, whereas in the mifepristone (Mife) group, a single dose of 10 mg mifepristone was taken and a placebo 12 hours after. Follow--up visit was paid on the seventh day of the expected next menstruation to evaluate the contraceptive efficacy and side effects. Contraceptive efficacy was calculated by Dixon’s method. Result:In the LNG group 20 pregnancies occurred among 643 women, while in the Mife group 9 pregnancies occurred among 633 women. The pregnancy rates were 3. 10% and 1. 43% respectively. Contraceptive efficacy rate of preventing pregnancy was 59. 16% and 79. 73%, the difference was statistically significant (P<O. 05). The incidence of various side effects, which were mild, was less than 10%. There was no statistical difference between the two groups. The percentage of subjects who had their next menstruation 3 days earlier or later than their expected menstruation in LNG group and Mife group was 77. 7% and 78. 5% respectively. Conclusion: Use of levonorgestrel or low dose mifepristone for emergency contraception is effective and safe.
文摘Objective To investigate possible causes resulting in the differences in the spermatogenesis suppression on individual treated with levonorgestrel (LNG) implants and testosterone undecanoate (TU) injectableMethods Totally 21 Chinese male volunteers were given treatment with LNG implants (four rods, 75 mg/rod) and intramuscular injection of TU (500 mg,bimonthly for 3 times). According to the effects of treatment, they were divided into two groups, namely, azoospermia group (group A) and oligozoospermia group (group O). Then seminal FSH, LH, T and estradiol (E2) were determined by immunoenzymetric assay, while seminal and serum dihydrotachysterol (DHT) and serum sex hormone binding globulin (SHBG) were by radioimmunoassay, and seminal transferrin (Tf) by scatter turbidimetry assay.Results Seminal FSH, LH and serum DHT, SHBG, FTI (T/SHBG ×100) levels were significantly lower in group A than in group O, while higher seminal concentrations ofE2 were observed in azoospermia group.Conclusion The differences in the spermatogenic suppression in Chinese men might be attributed to different rate of peripheral androgen metabolism, variations in serum SHBG levels, 5á-reductase activity and individual aromatase activity during LNG plus TU administration. In addition, seminal sex hormones might be more sensitive indexes to assess the extent of feedback inhibition on hypothalamus-pituitary-testis with exogenous testosterone plus progestogen in the efficacy hormone male contraceptive trials.
基金sponsored by the Natural Science Foundation of Liaoning Province(Nos.2022-YGJC-69,2021-BS-110)the support program for excellent young scholars of China Medical University.
文摘In this study,a new class of biodegradable contraceptive implants was prepared via the UV irradiation molding method,among which,progestin levonorgestrel(LNG)was used as a model drug.Photo-cross-linked aliphatic polycarbonates(APCs),namely,poly(trimethylene carbonate-co-2,2′-dimethyltrimethylene carbonate)[P(TMC-co-DTC)]elastomers,were used as the drug delivery matrix.The results obtained from the degradation experiments carried out in Sprague-Dawley(SD)rats showed that the cross-linked elastomer had the degradation characteristics of the surface erosion degradation mechanism,with no generation of acid degradation products,and excellent form-stability,which met the performance requirements of the matrix for a long-acting sustained-release delivery system.The in vitro cytotoxicity tests and histological and immunohistochemical evaluations showed good biocompatibility and biosafety of the elastomer matrix material and contraceptive implants.Subsequently,the implant formulations were screened by in vitro release experiments,and their release kinetics were explored.Finally,in the evaluation study of the in vivo anti-fertility effect,the implants exhibited excellent dimensional stability and were degraded by a surface erosion mechanism.LNG achieved a stable and sustained release in female SD rats,maintaining a long-acting contraceptive duration of up to 4 months.The contraceptive implants obtained in this study could be used to address the limitations of currently available formulations,which required secondary surgical removal and a single means of regulating drug release kinetics.Therefore,these implants could provide a new option for birth control needs and may be of significance in reducing the incidence of induced abortion and protecting female fertility.
文摘Introduction: Contraceptive implants are one of the most effective methods of birth spacing. Jadelle<sup>®</sup> implants consist of two strands that are easy to insert and remove. Although their effectiveness is no longer in question, their use (insertion) requires a surgical procedure with the corollary possibility of complications. These are mainly insertions that are too deep (in the arm muscle), vascular and nerve damage. Material and Methods: Our study focused on complications related to implant insertion. It was a descriptive and retrospective study over thirty-four months, from October 2016 to July 2019, and concerned all patients seen in consultation and who presented a complication related to the insertion of contraceptive implants in the Department of Gynecology and Obstetrics of the National Hospital of Pikine. Results: We collected nine complications managed at the Gynecology and Obstetrics Department of the Centre Hospitalier National de Pikine from 2016 to 2019. These were insertions that were too deep with sometimes nerve damage, infection or incident during anesthesia. The operative procedures were based on the type of complication. Conclusion: Although Jadelle<sup>®</sup> has the advantage of having only 2 rods compared to its predecessor Norplant<sup>®</sup>, its use is also conditioned by insertion and removal procedures which may experience complications.
文摘Objective: To compare the efficacy, side-effects and acceptability of domestic produced implant No. I and No. II with Norplant. Method: A multicentered randomized prospective clinical trial was conducted in ten centers in Chi na since 1993. Every center have recruited 100 cases for each of the three types of implants. Results: Altogether l, 001 cases of No. I, 1, 000 cases of No. II and 998 cases of Norplant were recruited. The follow--up rate was 99. 2% at the end of 24 months and 99. 1% at the end of 36 months. One pregnancy in No. I implant occurred & months after insertion and the net cumulative pregnancy rate was 0. 1 per 100 women. Total discontinuation rates were 15. 1, 14. 1, and 12. 9 per 100 women in NO. I, No. II and Norplant groups respectively. Among them about 75% of discontinuation was due to the menstrual problems. The incidence of side-effects were 22. 6%, 19. 0% and 19. 7% respectively at 36 months follow--up. There was no significant differences in efficacy and side effects among these three types of implant. Conclusion: The result of this three-years’ follow--up indicated that the domestic products implant No. I and No. II just as Norplant are long term, highly effective contraceptive and have been accepted in different area by different people. It will be widely selected by women of reproductive age in China.
文摘CaproF is a biodegradable subcutaneous contraceptive implant of releasing levonorgestrel (LNG), which is expected to provide an effective contraception for 2 years. This study was undertaken to assess the one year preliminary clinical results of using CaproF in 19 subjects. All subjects (n=19) completed the 1 year study, and the contraceptive effectiveness and follow up rate were both 100%. The incidence of side effects was low. The major side effects were menstrual disorder, but bleeding patterns tended to be improved and restored to be the same as pre implantation ones with time. There were no significant increase in weight (P>0.05) and no changes in blood pressure. In the 3 rd , 6 th and 12 th months after using CaproF, the cervical mucus became scanty and viscous without fern like crystals. The amount of menstrual blood loss decreased from 49.38 ml of pre implantation to 33.23 ml of the 12 th month of using the implant (P<0.05). Hemoglobin concentrations showed no changes, but serum ferritin concentrations were slightly increased. No changes in liver function, kidney function, glucose tolerance test and lipoprotein levels were found. Determinations of sex hormones (FSH, LH, E 2 and progesterone) levels, ultrasonography of ovary, and endometrial biopsy in observed group (n=9) showed that all had normal ovulation before insertion. But ovulation was suppressed and endometrium development was inhibited after insertion. All basal body temperatures were single phase patterns during the 1 year follow up. This study suggested that CaproF is an effective, safe and acceptable long acting contraceptive method. It is likely to reach its contraceptive effectiveness through suppressing ovulation, inhibiting endometrium development and influencing cervical mucus characteristics.
基金This study received partial financial support from the Fundaǎo de Amparo a Pesquisa do Estado de So Paulo (FAPESP), Brazil under award #03/083917.
文摘Objective To evaluate the prevalence of functional ovarian cysts in users of two different types of contraceptive implants. Methods A total of 239 women were enrolled at 3 months of use of the etonogestrelreleasing implant (Implanon) and the levonorgestrel-releasing implant (Jadelle). Bimanual pelvic examination and vaginal ultrasound were performed during routine 3, 6 and 12-month visits of asymptomatic women(control group). Women with ovarian cysts (or enlarged ovarian follicles 〉25 mm) (cysts group) were assessed weekly until disappearence or reduction of the image (including estradiol (E2) and progesterone measurement and women with no ovarian enlargement underwent same evaluation for the same period of time. Results Ovarian cysts were detected in 5.1% and 13.0% of users of Implanon and Jadelle, respectively, at 3rd month. At the 6th month of use, prevalences were 7.1% and 7.8%, and at 12th month rates were 25.7% and 14.7% in the two groups, respectively. E2 levels were significantly higher in cysts group than in control group. The time until disappearance of the ovarian cyst was similar in Implanon and Jadelle group. There were more cases of menorrhagia in patients rveth ovarian cysts than in patients with no ovarian enlargement. Conclusions The finding of ovarian cysts or enlarged ovarian follicles during the first year of use of Implanon and Jadelle implants is common and transient and should not be interpreted as a pathologic ovarian cyst. No further medical interventions are necessary.
文摘A multicentre comparative clinical study of CLa implant and Sino-implant was carried out at 100 subcentres in 11 provinces, and α total of 19673 subjects were recruited. Two-year follow-up has been finished. The follow-up rate at the end of two years was 94.29%. Two-year cumulative continuation rate per 100 women for Sino-implant(89.93) was significantly higher than that for CLa implant (88.89). Two-year cumulative pregnancy rates per 100 women were 0.0462(CLa implant) and 0.281(Sino-implant) respectively, there was statistically significant difference between them. No ectopic pregnancy was recorded among CLa implant users and three ectopic pregnancies were reported among Sino-implant users,resulting in an ectopic pregnancy rate of 0.163 per 1000 women-years. The incidence of side effects appeared to diminish with time. The major side-effects were the menstrual disturbances, which accounted for more than 90% of the total sideeffects, and the incidence of frequent menstruation, irregular bleeding and spotting was higher than that of infrequent/scanty menstruation and amenorrhea. Use of CLa implant had higher incidence of amenorrhea and infrequent/scanty menstruation than that of Sino-implant. During two-year follow-up, the number of discontinuation due to menstrual problems contributed 78% of the total number of discontinuation; two year menstrual-related cumulative discontinuation rates were 8.96 per 100 women for CLa implant and 7.84 for Sino-implant, there wasAddress coryespoll(lol,c'c toe D]' Fang ac juan, Shanghai Institute of Planned Pal.cnthood Research, 2140 Xit, 'I'u BOilal. Shanghai. 200032, China. Tel/F..f 86--021 64171432 E ..ill SIPPRms. STN. sh. C Nstatistically significant difference(P< 0.01). Two year study shows that the two types of implant are similar to Norplant in the incidence of side-effects and contraceptive efficacy as well as two year continuation rates.
文摘Unintended pregnancy rates remain high throughout the World and increase the risk of poor maternal and infant outcomes.Most of unintended pregnancies occur in women who were not using contraceptionor who became pregnant despite the reported use of contraception.Women who have had recent unprotected intercourse including those who have had another form of contraception fail are potential candidates for this intervention.Currently used em-ergency contraceptive methods are pills that contain combined estrogen-progesterone,only progestin,antiprogestins and copper intrauterine devices.The most common form of this type of contraception is oral progestin-only pills(levonorgestrel).The most effective method is copper intrauterine devices followed by anti-progestins and oral progestin-only pills.The major pathogenesis of oral emergency contraceptives is the prevention or delay of ovulation.Although conception is possible on only a few days of the cycle,emergency contraception is offered when indicated without regard to the timing of the menstrual cycle because of uncertainty in the timing of the ovulation.Levonorgestrel and E/P regimes are most effective as soon as possible after unprotected sexual intercourse.A linear relationship has been shown between ef-fectiveness and the time of dose.The effectiveness continues for 120 h,but it is recommended to be used within 72 h after intercourse.Intrauterine devices may prevent pregnancy when 5 d after ovulation.
文摘Objective: To assess levonorgestrel-releasing intrauterine system LNG-IUS (Mirena?) application at caesarean section (CS). Design: Randomized, comparative study. Setting: Department of obstetrics and gynecology in a primary reference hospital at Puebla City, Mexico. Sample: 396 women requiring CS signed informed consent and were randomly allocated to the post-placental application of LNG-IUS (198) or Copper T 380 A (198). Methods: Follow up visits at 6 weeks, and 6 and 12 months were performed. Main Outcomes Measures: IUDs expulsion, maternal and babies’ health conditions, breastfeeding and menstrual patterns, adverse effects and pregnancies. Differences between groups were analyzed by Fisher and X2 tests, Odds ratios, relative risk and 95% confidence limits, as appropriate. Results: After one year of follow up, no pregnancies were reported. The IUD expulsion rate was 4.5% in each group. LNG-IUS users had a higher incidence of amenorrhea (OR 2.5 95% CI 2.2 - 3) and menstrual patterns significantly brief and lighter than Copper T 380 A (p < 0.001) with lower incidence of dysmenorrhea (OR 0.1 95% CI 0.04 - 0.2). No detrimental effects of LNG-IUS on breastfeeding was observed and interestingly babies weights of LNG-IUS users was slightly above the average for age compared with Copper T 380 A users. This was probably related with a major proportion of women with normal ferritin serum levels (94% vs 68%) leading to better mother’s general condition. Conclusions: LNG-IUS inserted during CS provides high efficacy contraception with additional benefits, mainly reducing menstrual bleeding and doing so, faster recovery of ferrous homeostasis after CS.
文摘Objective To develop a new contraceptive implant containing gestodene featuring with only one rod for 5 years long effectiveness and safety. Methods Gestodene synthesis, polymer tube designatiou, in vitro or in vivo test, the pilot test was used for the establishing of minimum clinic dosage. Results It had a burst effect at beginning and become constantly releasing since 12th day. It had zero-order releasing, in vitro, the average releasing rate was 17.0-19.1μg/d, the safe dosage was 70.2mg/kg, C1hr. was 2.91 ± 1.25 ng/ml, Tmax was 8.86± 4.32 h, C was 7.31 ± 1.09 ng/ml, Tss was 14 d, Css was 4.16 ±0.48 ng/ml. Twenty-four hours later after removal of the implant, gestodene was ahnost cleaned out in the blood circulation and only trace amount of drug was detected after the removal. Conclusion One rod gestodene implant is a new tong effective contraceptive and may be promising.
文摘Objective: To document our experience on the use of Jadelle/Implanon contraceptives that was recently introduced into Ahmadu Bello University Teaching Hospital (ABUTH), Zaria, Nigeria. It is pertinent to generate data on the experiences in the use of this contraceptive in a cross sectional study within Zaria, Northern Nigeria. Method: Data on consecutive clients that accepted Jadelle/ Implanon from June 2009 to November 2013 at ABUTH were extracted from their cards and analyzed using SPSS version 17. Out of a total of 11,502 clients that were for contraception during the period under review, 798 accepted Jadelle/Implanon accounting for 7% of the total clients. All the clients were married. About 67.8% were Muslims while 27.2% were Christians and 5% belong to other sect. 4140 (36%) had tertiary education. Most of the client has been on one form of modern contraception;only 16% were first time users who accepted implant after counselling. 37% of the?clients are full time housewives. The discontinuation rate was found to be 26% for Jadelle and 19%?for Implanon. No pregnancy was recorded during this period. Conclusion: Jadelle/Implanon account for 7% of contractive uptake and a high discontinuation rate was found among the users.
基金supported by grants from the Sanming Project of Medicine in Shenzhen,China(SZSM201612083 to W.S.-B.Y.)Shenzhen Key Medical Discipline(SZXK2020089)+1 种基金General Research Fund,Research Grants Council,Hong Kong(17120720 to K.-F.L.)internal research funding from the Department of Obstetrics and Gynaecology,the University of Hong Kong.
文摘This review summarizes the drugs and chemicals that may modulate embryo implantation.Non-hormonal molecules,including aspirin,improved endometrial blood flow,while low molecular weight heparin,vitamin E,sildenafil,and atosiban modulated the expression of endometrial genes.Hormonal factors,including human chorionic gonadotropin and growth hormones,can regulate the expression of endometrial receptivity markers.Other immunomodulatory molecules,including granulocyte colony-stimulating factor,peripheral blood mononuclear cells,autologous platelet-rich plasma,and intralipid and intravenous immunoglobulins,may improve implantation rate by modulating endometrial immune functions.Medicinal extracts of the Chinese herbs Paeonia lactiflora and Perilla frutescens increased the expression of leukemia inhibitory factors in endometrial epithelial cells.Recently,the use of the commercially available Library of Pharmacologically Active Compounds with a high-throughput screening method has provided an approach to screen for compounds that may potentially enhance or suppress embryo implantation.Whether these biomedical findings translate into clinical effects that enhance or suppress embryo implantation requires further investigation.
文摘The purpose of this study was to use a kind of safe,long acting and reversible hormonal regimen for male contraception .The studied regimen was a subdermal insertion of a two rod implant (Sino implant, each rod containing 75 mg levenorgestrel LNG) in each subject's forearm, followed 3 weeks after by monthly injection of TU (Testosterone Undecanoate 250 mg) for 3 months. Eighteen weeks after implantation, the Sino implant was removed. There were altogether 16 male volunteers recruited in the entire research program. Among them 6 cases reached azoospermia; one case reached oligozoospermia (sperm density <3 million/ml); 5 cases' sperm density declined greatly, the lowest to be 5.7±1.3 million/ml; the other four cases' sperm density also declined, but remained within normal range (above 20 million/ml), the lowest to be 24.5±9.0 million/ml. The duration to reach azoospermia was 16.7±0.5 weeks. The duration to resume to normal range of sperm density was 8.2±2.5 weeks in the subjects with azoospermia and oligozoospermia. In the first two weeks after insertion the LNG release of Sino implant's mean serum LNG level was about 0.38 ng/ml, in the rest of the time the LNG levels in blood was rather constant about 0.24 ng/ml. Routine analyses of blood and urine, liver and kidney functions, and blood chemistry including those parameters (TG,TC,HDL C,LDL C) of lipid metabolism didn't change much throughout the research. All the subjects' libido and sex function were well kept. Clinical observation didn't show any other adverse effects during the research.
文摘We have investigated the feasibility of administration of testosterone undecanoate (TU)-Ioaded injectable in situ-forming implant (ISFI) for contraception in adult male Sprague-Dawley rats. Male rats were treated with vehicle, TU-Ioaded ISFIs (540, 270 and 135 mg TU kg-1) or TU injections (45 mg TU kg-1 every 30 days) for 120 days. Fertility tests served for determining infertility or restoration of fertility in treated rats. Serum testosterone concentration, epididymal sperm count, motility, morphology, and histology of the testis were monitored. The TU-Ioaded ISFIs increased serum testosterone levels in rats steadily without fluctuation over 3 months. One month after TU administration, the epididymal sperm count decreased significantly in all experimental groups. After 3 months, the animals treated with 270 and 135 mg kg-~ TU-Ioaded ISFIs were 100% infertile, and no implantation sites were produced in the mated females. However, some of males treated with 540 mg kg-~ ISFI or TU injections were still fertile but numbers of implantation sites were also significantly lower than control values. TU-Ioaded ISFI at an appropriate dose has potential as a long-acting male contraceptive drug that suppresses spermatogenesis consistently over a period of 3 months.