Estradiol 1mg / Dydrogesterone 10mg tablets

BackgroundA normal luteal function is an essential factor for maintaining pregnancy; luteal phase deficiency decreases embryo implantation and pregnancy rate and increases the early miscarriage rate. In stimulated in vitro fertilization-embryo transfer (IVF-ET) patients, luteal phase support (LPS) is achieved by the exogenous supplementation with progesterone to increase endometrial receptivity and pregnancy. While several protocols exist, no commonly accepted protocol has been established for optimal luteal support after IVF-ET to date, the purpose of this study was to investigate the effect of two different luteal phase support protocols in patients undergoing assisted reproductive technologies.MethodsIn a prospective open, randomized study conducted in a private IVF Unit a total of 700 infertile patients, undergoing in vitro fertilization treatment, were recruited for this study. All patients had a mild ovarian stimulation protocol with GnRH antagonist. The patients were randomized into two groups based on the type of luteal phase support route: Group A, control group (n = 310) patients received our routine LPS protocol which consists of the administration of 800 mg of micronized vaginal progesterone and Group B, study group, (n = 310) patients received a combination of oral dydrogesterone 20 mg and 90 mg of a gel of vaginal micronized progesterone Pregnancy rate, live birth rate, implantation rate and miscarriage rate were evaluated as primary endpoints. Statistical analysis was performed using JMP software (version 17; SAS, Inc., Cary, NC, USA). A P ≤ 0.05 was considered statistically significant.ResultsNo differences were observed between the two groups in terms of pregnancy rate (Group A 34,9% vs. Group B 35,7%), live birth rate (Group A 30,6% vs. Group B 29,2%), miscarriage rate (Group A 12% vs. Group B 18%) and implantation rate (Group A 18,6% vs. Group B 17,1%).ConclusionsThe combination of two different formulations of progesterone (vaginal and oral) for luteal phase support does not improve IVF outcomes when compared to the vaginal route of progesterone administration alone.Trial registrationThe study has been retrospectively registered with the Clinical Trials registry reference number ISRCTN52148405 ( http://isrctn.org/ ).

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BackgroundThe introduction of vitrification has markedly increased frozen embryo transfer (FET) cycles, driving efforts to optimize FET protocols. In artificial-cycle FET (AC-FET), micronized vaginal progesterone (MVP) is widely used for luteal phase support (LPS), though local side effects are common. Dydrogesterone (DYD), an oral selective progesterone receptor agonist, offers patient-friendly administration, but its efficacy in AC-FET remains uncertain.MethodsIn this single-centre trial (October 2021 - September 2023), women ResultsOf 167 screened, 150 were randomized (Group A: 73; Group B: 77). Baseline and cycle characteristics were comparable. Four women switched LPS post-randomization; both per-protocol and intention-to-treat analyses were performed. OPR was 31·5% with DYD vs 45·2% with MVP (p=0·09; difference -13%, 95% CI -38 to 12). ITT analysis was consistent (31·1% vs 44·7%).ConclusionAlthough not statistically significant, the results of this pilot prospective randomized controlled trial may have clinical implications and highlight the need for larger studies investigating the ideal dose and administration route of different LPS medications in AC-FET cycles. Given the differences in pharmacological profiles, varying dosages and more frequent administration of DYD may also warrant exploration.

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ObjectiveThis study aimed to evaluate the clinical efficacy of Jia Wei Shoutai Wan (JWSTW) combined with dydrogesterone in patients with threatened abortion (TA) complicated by endometrial cavity fluid (ECF).MethodsThis was a prospective, single-center, randomized controlled trial. A total of 130 patients with TA and ECF admitted to our hospital from January to November 2022 were screened. Thirteen patients did not meet the inclusion criteria, and five refused to participate, leaving 112 eligible participants. Using a random number table, patients were assigned to a control group (dydrogesterone alone, n = 56) or a combination group (dydrogesterone plus JWSTW, n = 56). Both groups received continuous treatment for 14 days. During follow-up, 3 patients withdrew and 6 were excluded, resulting in 103 cases included in the final analysis (control group, n = 50; combination group, n = 53). The primary outcomes were ECF area and Traditional Chinese Medicine (TCM) syndrome scores (vaginal bleeding, lower abdominal pain, fatigue and tiredness, knee soreness, and lumbago) after 14 days of treatment. Secondary outcomes included serum levels of progesterone (P), β-human chorionic gonadotropin (β-HCG), and estradiol (E2); coagulation indices [D-dimer (D-D), fibrinogen (FIB), and prothrombin time (PT)]; clinical efficacy; and adverse reactions.ResultsAfter treatment, the combination group showed significantly lower TCM symptom scores and a smaller ECF area (p p p = 0.360). The overall clinical efficacy of the combination group was superior to that of the control group (p ConclusionJWSTW combined with dydrogesterone may be beneficial for treating TA with ECF by improving clinical symptoms, optimizing hormone and coagulation profiles, and reducing ECF without increasing adverse reactions.

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Study questionDoes adding vaginal estradiol to standard progesterone luteal phase support improve ongoing pregnancy rates in normal-responder IVF/ICSI patients undergoing GnRH antagonist cycles?Summary answerThe addition of vaginal estradiol to progesterone luteal support in GnRH antagonist cycles, compared to progesterone alone, enhances embryo implantation and clinical pregnancy rates in normal-responder IVF/ICSI patients, yet fails to significantly improve ongoing pregnancy or live birth outcomes.What is known alreadyThe GnRH antagonist protocol for IVF, while advantageous in some aspects, may negatively impact estrogen levels and endometrial receptivity, potentially lowering fresh embryo transfer pregnancy rates compared to agonist protocols. The role of adding estrogen to standard progesterone luteal phase support in antagonist cycles remains controversial, with existing studies yielding conflicting results and a lack of robust randomized controlled trials (RCTs) specifically investigating vaginal estrogen administration.Study design size durationIn this single-centre RCT, participants were randomized 1:1 on the ovulation trigger day to receive either progesterone alone (P group) or progesterone plus vaginal 17β-estradiol (E + P group) for luteal phase support, starting on Day 1 post-oocyte retrieval. The sample size calculation, based on detecting a clinically significant 13% difference in ongoing pregnancy rate (43% vs 30%; α = 0.05, power = 80%) with an anticipated 10% attrition, determined a target of 236 women per group. A total of 518 women (P group: n = 259; E + P group: n = 259) were enrolled between April 2019 and June 2022. Allocation used computerized randomization by an independent data manager. Blinding of participants and physicians was not feasible; however, statisticians were blinded until analysis completion. The analysis was performed using intention-to-treat (ITT) and per-protocol (PP), followed by a sensitivity analysis using multivariable logistic regression.Participants/materials setting methodsThis single-centre trial enrolled 518 infertile women (20-39 years) undergoing fresh IVF/ICSI cycles as normal responders at a tertiary care centre. Participants were allocated to either the P group or E + P group. Luteal support initiated on Day 1 post-oocyte retrieval comprised: vaginal progesterone 90 mg/day + oral dydrogesterone 10 mg twice daily for both groups, with the E + P group additionally receiving vaginal 17β-estradiol 2 mg nightly. The primary outcome was ongoing pregnancy rate, with secondary outcomes including the rates of implantation, clinical pregnancy, live birth, and maternal complications.Main results and the role of chanceThe ITT analysis showed no significant differences in ongoing pregnancy rates of 46.33% (120/259) in the E + P group versus 39.00% (101/259) in the P group (RR 1.19, 95% CI: 0.97-1.45; P = 0.091), with the PP analysis yielding 48.78% (120/246) versus 41.39% (101/244) (RR 1.18, 95% CI: 0.97-1.44; P = 0.1). Implantation rates, in both the ITT and PP analyses, favoured the E + P group (39.66% vs 32.96%; RR 1.20, 95% CI: 1.01-1.43; P = 0.035), and clinical pregnancy rates were significantly higher in the E + P group both by ITT (53.28% vs 44.02%; RR 1.21, 95% CI: 1.01-1.44; P = 0.035) and PP analyses (56.10% vs 46.72%; RR 1.20, 95% CI: 1.01-1.43; P = 0.038). No significant differences were observed in live birth rates. Notably, intrahepatic cholestasis of pregnancy (ICP) occurred more frequently in the E + P group (5.17% vs 0%, P = 0.032), however, this difference was no longer statistically significant after multivariable adjustment (Adjusted P = 0.996).Limitations reasons for cautionThe increase in ICP in the estradiol group is a major safety concern requiring cautious interpretation, despite the improvement in some intermediate outcomes, such as implantation and clinical pregnancy. The lack of significant benefit on the primary outcome, ongoing pregnancy, and live birth limits the clinical utility.Wider implications of the findingsThe addition of vaginal luteal estradiol supplementation in GnRH antagonist cycles improves embryo implantation and clinical pregnancy rates, yet fails to demonstrate significant benefits in ongoing pregnancy or live birth outcomes for IVF/ICSI patients. This intervention was associated with an increased risk of ICP compared to that in progesterone-only controls, highlighting the need for clinical vigilance regarding maternal safety. Although there was no significant between-group difference in the incidence of ICP in the sensitivity analysis, this null finding is likely due to the small number of events and limited statistical power. Notably, ICP should remain a safety signal that warrants attention when estrogen supplementation is administered during early pregnancy. These findings indicate that while estradiol supplementation may enhance early reproductive endpoints, its clinical utility remains uncertain due to the absence of ultimate efficacy improvement and emerging safety concerns.Study funding/competing interestsThe grant support was provided by: the Key R&D Program of Zhejiang (2024C03199), Zhejiang Provincial Medical and Health Technology Plan (2020KY620, 2025KY1176), Zhejiang Provincial Natural Science Foundation of China (LQ24H040002, LHZQN26H280003), Administration of Traditional Chinese Medicine of Zhejiang Province, China (2024ZL740), and Hangzhou Municipal Special Fund for the Development of the Biomedicine and Health Industry (2023WJC327). There are no conflicts of interest to declare.Trial registration numberChiCTR1900022631.Trial registration date19 April 2019.Date of first patient’s enrolment20 April 2019.

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BackgroundPerimenopausal symptoms affect most women and often substantially impair their quality of life, whereas conventional estrogen therapy alone does not fully address clinical needs. Baoqing granules (BQG), derived from Zuo Gui Wan in Jingyue's Complete Works, were modified to target kidney Yin deficiency and have shown promising clinical efficacy, although robust randomized evidence remains limited.MethodsThe trial was registered with the Chinese Clinical Trial Registry (ChiCTR2300073338; http://www.chictr.org.cn). In this randomized, double-blind, placebo-controlled clinical trial, eligible perimenopausal women received either Femoston plus placebo or Femoston plus BQG for four weeks, followed by a four-week follow-up. The primary outcomes were the Modified Kupperman Menopausal Index (Modified KMI) and traditional Chinese medicine (TCM) syndrome scores. Secondary outcomes included the Menopause-Specific Quality of Life Questionnaire (MENQOL), Pittsburgh Sleep Quality Index (PSQI), Self-Rating Anxiety Scale (SAS), Self-Rating Depression Scale (SDS), and serum levels of sex hormones and lipids. Safety was evaluated through hepatic and renal function tests and adverse-event monitoring.ResultsBoth groups showed significant improvements from baseline; however, participants in the BQG group experienced greater short-term improvements that persisted at week 8 in Modified KMI, TCM syndrome scores, MENQOL, and PSQI, while differences in SAS and SDS became significant only at follow-up. Hormone and lipid profiles showed no overall between-group differences, although exploratory subgroup analyses suggested higher estradiol and lower follicle-stimulating hormone levels in postmenopausal women receiving BQG. Liver and kidney functions remained within normal ranges, and only one mild adverse event was reported.ConclusionIn this 8-week study, BQG as an adjunct to Femoston was associated with additional short-term improvements in multidimensional perimenopausal symptoms, with acceptable tolerability. These findings support the potential role of BQG as a complementary therapy; however, longer-term studies are needed to confirm the durability of benefit and long-term safety.Clinical trial registrationhttp://www.chictr.org.cn, identifier ChiCTR2300073338.

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