Estradiol 2mg / Dydrogesterone 20mg 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/ ).

Abstract licence: CC BY-NC-ND

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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