Background:?Luteal phase support is indicated after Controlled Ovarian Stimulation (COS) using Long Gonadotropin-Releasing Hormone Agonist (GnRHa) protocol in Women undergoing in Vitro Fertilization (IVF)/Intracytopla...Background:?Luteal phase support is indicated after Controlled Ovarian Stimulation (COS) using Long Gonadotropin-Releasing Hormone Agonist (GnRHa) protocol in Women undergoing in Vitro Fertilization (IVF)/Intracytoplasmic Sperm Injection (ICSI). Progesterone is widely used for this indication. Objective: The objective of the current trial is to compare both efficacy and safety of oral dydrogesterone and vaginal micronized progesterone in luteal phase support in women undergoing IVF/ICSI using the long GnRHa protocol. Methods: This open-label randomized controlled study conducted at a private fertility and IVF center in Zagazig, Egypt, during the interval between April 2016 and August 2019. The study included women planned to undergo IVF/ICSI for either male factor infertility, tubal factor infertility, or unexplained infertility. Women with pelvic endometriosis, known reduced ovarian reserve, and women who were known to have poor or high response to ovarian stimulation, as well as women who were stimulated using non-long GnRHa protocol were not included. After embryo transfer, eligible women were randomly allocated into one of the two groups: group I, included women who received oral dydrogesterone 10 mg three times per day;and group II, included women who received vaginal micronized progesterone 400 mg twice per day. The primary outcome was live birth rate. The principal secondary outcome was women satisfaction. Results: Five hundred sixty four women were recruited and randomly allocated into two groups: group I [Oral Dydrogesterone Group] (n = 284), and group II [Vaginal Progesterone Group] (n = 280). Live birth rates [72 (25.4%) vs 69 (24.6%), respectively, RR 1.03, 95% CI (0.77 to 1.37)], ongoing pregnancy rates [79 (27.8%) vs 81 (28.9%), respectively, RR 0.96, 95% CI (0.74 to 1.25)], clinical pregnancy rates [97 (34.2%) vs 95 (33.9%), respectively, RR 1.01, 95% CI (0.80 to 1.27)] and miscarriage rates (per clinical pregnancy) [18 (18.6%) vs 14 (14.7%), respectively, RR 1.26, 95% CI (0.66 to 2.38)] were all comparable in both groups. The rates of vaginal burning [4 (1.4%) vs 32 (11.4%), respectively, RR 0.12, 95% CI (0.04 to 0.34)], vaginal bleeding [9 (3.2%) vs 26 (9.3%), respectively, RR 0.34, 95% CI (0.16 to 0.72)] and overall dissatisfaction [15 (5.3%) vs 68 (24.3%), respectively, RR 0.22, 95% CI (0.13 to 0.37)] were significantly lower among women of group I when compared to women of group II. Conclusion: In conclusion, when compared to vaginal micronized progesterone, oral dydrogesterone seems to be associated with comparable live birth, ongoing pregnancy and clinical pregnancy rates, and significantly lower dissatisfaction and side effects rates, when given as luteal phase support in normal responding women undergoing IVF/ICSI using the long GnRHa protocol.展开更多
Objective:To determine whether a single dose of gonadotropin-releasing hormone(GnRH)agonist administered subcutaneously in addition to the regular progesterone supplementation could provide a better luteal support in ...Objective:To determine whether a single dose of gonadotropin-releasing hormone(GnRH)agonist administered subcutaneously in addition to the regular progesterone supplementation could provide a better luteal support in antagonist protocol fresh embryo transfer cycles.Methods:This prospective,multicentric,cohort study included total 140 women,70 in each group.Controlled ovarian stimulation was carried out as per fixed GnRH antagonist protocol.The trigger was given with hCG.In vitro fertilization/intracytoplasmic sperm injection(IVF/ICSI)was performed and day-3 embryos were transferred.Patients were divided into groups 1 and 2 based on computer generated randomization sheet.Six days following oocyte retrieval,group 1 received 0.2 mg decapeptyl subcutaneously in addition to regular progesterone support while group 2 received progesterone only.Luteal support was given for 14 days to both groups;if pregnancy was confirmed luteal support was continued till 12 weeks of gestation.The clinical pregnancy rate was the primary outcome.The implantation rate,miscarriage rate,live birth delivery rate,and multiple pregnancy rates were the secondary outcomes.Results:A total of 140 patients were analysed,70 in each group.Clinical pregnancy rates(47.1%vs.35.7%;P=0.17),implantation rates(23.4%vs.18.1%,P=0.24),live birth delivery rates(41.4%vs.27.1%,P=0.08),and multiple pregnancy rates(21.2%vs.16.0%,P=0.74)were higher in group 1 than in group 2.Group 1 had a lower miscarriage rate than group 2(5.7%vs.8.6%;P=0.75).However,these differences were not statistically significant between the two groups.Conclusions:Administration of a single dose of GnRH agonist in addition to regular natural micronized vaginal progesterone as luteal support in GnRH antagonist protocol cycles marginally improves implantation rates,clinical pregnancy rates,and live birth delivery rates.However,more studies with higher sample sizes are needed before any conclusive statements about GnRH agonist as luteal phase support can be made.展开更多
Background: Luteal phase support with GnRH agonist administration has been shown to be effective in improving the outcome of assisted reproductive technology. The goal of this study was to evaluate the effect of singl...Background: Luteal phase support with GnRH agonist administration has been shown to be effective in improving the outcome of assisted reproductive technology. The goal of this study was to evaluate the effect of single dose Triptrolin (a GnRH agonist) on the probability of the clinical pregnancy rate following embryo transfer (ET) in assisted reproductive techniques (ART). Methods: In this double blinded randomized clinical trial, 340 infertile women who were candidates for intra-cytoplasmic sperm injection (ICSI) were randomly assigned to receive GnRH agonist (Triptrolin) in the luteal phase or placebo. In the intervention group, 0.1 mg Triptrolin was injected subcutaneously, while the control group received normal saline. The clinical pregnancy and implantation rate were compared between the two groups using chi-2 and t-test. P-values less than 0.05 were considered significant. The registration number of this clinical trial is IRCT 2014030916912N1. Results: Administration of 0.1 mg Triptrolin on day 6 after oocyte pick up showed no superiority over placebo in implantation (16.9% - 14%, P = 0.40) and clinical pregnancy rates (32% - 29%, P = 0.66), but the rate of clinical pregnancy was higher in women who were below 27 years of age and those with PCO. Conclusion: Administration of Triptrolin was not superior to placebo for luteal phase support.展开更多
文摘Background:?Luteal phase support is indicated after Controlled Ovarian Stimulation (COS) using Long Gonadotropin-Releasing Hormone Agonist (GnRHa) protocol in Women undergoing in Vitro Fertilization (IVF)/Intracytoplasmic Sperm Injection (ICSI). Progesterone is widely used for this indication. Objective: The objective of the current trial is to compare both efficacy and safety of oral dydrogesterone and vaginal micronized progesterone in luteal phase support in women undergoing IVF/ICSI using the long GnRHa protocol. Methods: This open-label randomized controlled study conducted at a private fertility and IVF center in Zagazig, Egypt, during the interval between April 2016 and August 2019. The study included women planned to undergo IVF/ICSI for either male factor infertility, tubal factor infertility, or unexplained infertility. Women with pelvic endometriosis, known reduced ovarian reserve, and women who were known to have poor or high response to ovarian stimulation, as well as women who were stimulated using non-long GnRHa protocol were not included. After embryo transfer, eligible women were randomly allocated into one of the two groups: group I, included women who received oral dydrogesterone 10 mg three times per day;and group II, included women who received vaginal micronized progesterone 400 mg twice per day. The primary outcome was live birth rate. The principal secondary outcome was women satisfaction. Results: Five hundred sixty four women were recruited and randomly allocated into two groups: group I [Oral Dydrogesterone Group] (n = 284), and group II [Vaginal Progesterone Group] (n = 280). Live birth rates [72 (25.4%) vs 69 (24.6%), respectively, RR 1.03, 95% CI (0.77 to 1.37)], ongoing pregnancy rates [79 (27.8%) vs 81 (28.9%), respectively, RR 0.96, 95% CI (0.74 to 1.25)], clinical pregnancy rates [97 (34.2%) vs 95 (33.9%), respectively, RR 1.01, 95% CI (0.80 to 1.27)] and miscarriage rates (per clinical pregnancy) [18 (18.6%) vs 14 (14.7%), respectively, RR 1.26, 95% CI (0.66 to 2.38)] were all comparable in both groups. The rates of vaginal burning [4 (1.4%) vs 32 (11.4%), respectively, RR 0.12, 95% CI (0.04 to 0.34)], vaginal bleeding [9 (3.2%) vs 26 (9.3%), respectively, RR 0.34, 95% CI (0.16 to 0.72)] and overall dissatisfaction [15 (5.3%) vs 68 (24.3%), respectively, RR 0.22, 95% CI (0.13 to 0.37)] were significantly lower among women of group I when compared to women of group II. Conclusion: In conclusion, when compared to vaginal micronized progesterone, oral dydrogesterone seems to be associated with comparable live birth, ongoing pregnancy and clinical pregnancy rates, and significantly lower dissatisfaction and side effects rates, when given as luteal phase support in normal responding women undergoing IVF/ICSI using the long GnRHa protocol.
文摘Objective:To determine whether a single dose of gonadotropin-releasing hormone(GnRH)agonist administered subcutaneously in addition to the regular progesterone supplementation could provide a better luteal support in antagonist protocol fresh embryo transfer cycles.Methods:This prospective,multicentric,cohort study included total 140 women,70 in each group.Controlled ovarian stimulation was carried out as per fixed GnRH antagonist protocol.The trigger was given with hCG.In vitro fertilization/intracytoplasmic sperm injection(IVF/ICSI)was performed and day-3 embryos were transferred.Patients were divided into groups 1 and 2 based on computer generated randomization sheet.Six days following oocyte retrieval,group 1 received 0.2 mg decapeptyl subcutaneously in addition to regular progesterone support while group 2 received progesterone only.Luteal support was given for 14 days to both groups;if pregnancy was confirmed luteal support was continued till 12 weeks of gestation.The clinical pregnancy rate was the primary outcome.The implantation rate,miscarriage rate,live birth delivery rate,and multiple pregnancy rates were the secondary outcomes.Results:A total of 140 patients were analysed,70 in each group.Clinical pregnancy rates(47.1%vs.35.7%;P=0.17),implantation rates(23.4%vs.18.1%,P=0.24),live birth delivery rates(41.4%vs.27.1%,P=0.08),and multiple pregnancy rates(21.2%vs.16.0%,P=0.74)were higher in group 1 than in group 2.Group 1 had a lower miscarriage rate than group 2(5.7%vs.8.6%;P=0.75).However,these differences were not statistically significant between the two groups.Conclusions:Administration of a single dose of GnRH agonist in addition to regular natural micronized vaginal progesterone as luteal support in GnRH antagonist protocol cycles marginally improves implantation rates,clinical pregnancy rates,and live birth delivery rates.However,more studies with higher sample sizes are needed before any conclusive statements about GnRH agonist as luteal phase support can be made.
文摘Background: Luteal phase support with GnRH agonist administration has been shown to be effective in improving the outcome of assisted reproductive technology. The goal of this study was to evaluate the effect of single dose Triptrolin (a GnRH agonist) on the probability of the clinical pregnancy rate following embryo transfer (ET) in assisted reproductive techniques (ART). Methods: In this double blinded randomized clinical trial, 340 infertile women who were candidates for intra-cytoplasmic sperm injection (ICSI) were randomly assigned to receive GnRH agonist (Triptrolin) in the luteal phase or placebo. In the intervention group, 0.1 mg Triptrolin was injected subcutaneously, while the control group received normal saline. The clinical pregnancy and implantation rate were compared between the two groups using chi-2 and t-test. P-values less than 0.05 were considered significant. The registration number of this clinical trial is IRCT 2014030916912N1. Results: Administration of 0.1 mg Triptrolin on day 6 after oocyte pick up showed no superiority over placebo in implantation (16.9% - 14%, P = 0.40) and clinical pregnancy rates (32% - 29%, P = 0.66), but the rate of clinical pregnancy was higher in women who were below 27 years of age and those with PCO. Conclusion: Administration of Triptrolin was not superior to placebo for luteal phase support.
