Dydrogesterone treatment for menstrual-cycle regularization in abnormal uterine bleeding-ovulation dysfunction patients

BACKGROUND Dydrogesterone has shown significant efficacy in treatment of irregular menstrual cycle due to abnormal uterine bleeding-ovulation dysfunction(AUB-O),but there were few relevant studies.This observational study was designed to evaluate the effectiveness of dydrogesterone for the treatment of Chinese patients with AUB-O.AIM To evaluate the effects of dydrogesterone on menstrual-cycle(MC)regularization and metabolism in the patients with AUB-O.METHODS A prospective,non-interventional,single-arm,post-marketing observational study was conducted.Chinese women aged 16 years or above with AUB-O who had been prescribed dydrogesterone were enrolled.The patients were treated with dydrogesterone 10 mg from day 16 to day 25 of each cycle,consecutively for at least 3 cycles.The main outcome was defined as the percentage of patients whose MCs returned to normal(defined as 21 d<menstrual cycle≤35 d)after three cycles of dydrogesterone treatment.RESULTS One hundred and fourteen women with AUB-O were enrolled in the present study.Of 89 patients who completed treatment,72(80.9%)achieved a regular MC at the end of the 3rd circle.The level of androgen,including testosterone and dehydroepiandrosterone sulfate,declined significantly(P=0.01 and 0.031,respectively),whereas other hormone levels remained steady.During the treatment,44/80(55.0%)subjects in the per-protocol set had reported biphasic basal body temperature.CONCLUSION Dydrogesterone therapy was effective in achieving MC regularization for Chinese patients with AUB-O.

Oral Dydrogesterone versus Vaginal Micronized Progesterone in Luteal Phase Support after Controlled Ovarian Stimulation Using Long Gonadotropin-Releasing Hormone Agonist in Women Undergoing in Vitro Fertilization/Intracytoplasmic Sperm Injection

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.

Best time for progesterone supplementation in aid ovulation induction cycles by letrozole

Objective:To explore the best time for progesterone supplementation in AID ovulation induction cycles by Letrozole.Methods: The data analysed in this study were collected from 509 patients who were performed AID (Artificial Insemination by Donor) administrated letrozole (LE) between 2014.8-2015.7. All patients were randomly divided into 4 groups by the time of progesterone administrated, including experimental group and the control group. The experimental group was divided into group 1-72 h after ovulation, group 2-48 h after ovulation, group 3-24 h after ovulation and control group—without administrated LE. The gestation and live birth rate were evaluated by monitoring vaginal ultrasound and HCG blood value 14 d after AID.Results: The pregnancy rate with administrated progesterone added 72 h after ovulation was 31.9%, which was significantly higher than those of other groups, the same situation as groups added progesterone was significantly higher than the control group. However, there was no significant difference in the numbers of abortions among the four groups. The LBR of group 4 was significantly lower than that of group 1.Conclutions: Progesterone administrated 72 h after ovulation can promoted the gestation rate, but did not affect the rate of miscarrage .