What question did this study set out to answer?

This trial aims to evaluate the efficacy of dydrogesterone compared to micronized vaginal progesterone for luteal phase support in artificial-cycle frozen embryo transfer.

April 20, 2026Open Access

Dydrogesterone versus micronized vaginal progesterone for luteal phase support in artificial cycle frozen embryo transfer (REMODEL): a pilot prospective randomized controlled trial

Key Points

This trial aims to evaluate the efficacy of dydrogesterone compared to micronized vaginal progesterone for luteal phase support in artificial-cycle frozen embryo transfer.
Single-centre trial with women under 41 years and normal BMI undergoing single blastocyst frozen embryo transfer.
Participants randomized to receive either dydrogesterone or micronized vaginal progesterone for luteal phase support.
All participants received estradiol valerate for endometrial preparation.
Primary outcome measured was ongoing pregnancy rate at 12 weeks.
Ongoing pregnancy rate was 31.5% for dydrogesterone and 45.2% for micronized vaginal progesterone (p=0.09).
Intention-to-treat analysis showed similar ongoing pregnancy rates: 31.1% for dydrogesterone and 44.7% for micronized vaginal progesterone.
The differences were not statistically significant but indicate a trend towards higher efficacy with micronized vaginal progesterone.

Abstract

Background The 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. Methods In this single-centre trial (October 2021 - September 2023), women 41 years with normal BMI undergoing single blastocyst AC-FET were randomized (1:1) to DYD 10 mg three times daily (Group A) or MVP 200 mg twice daily (Group B). All received estradiol valerate for endometrial preparation. The primary outcome was ongoing pregnancy rate (OPR) at 12 weeks. Results Of 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%). Conclusion Although 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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