MIcronized PROgesterone in Frozen Embryo Transfer Cycles

• Status: Not yet recruiting
• Trial end date: 2026-04-01
• Target enrollment: 0
• Participant gender: Female

Summary

This randomized trial was designed as non-inferiority trial aiming to compare ongoing pregnancy rates following LPS with 600 mg/day vs 800 mg/day vaginal VMP. All patients will undergo an artificial cycle frozen embryo transfer (AC-FET) with transdermal estradiol 6mg/day Patients undergoing an artificial cycle FET will start estrogen priming with transdermal estradiol 6mg/day (Estrogel®) on cycle D1-D3. Following 10-12 days of estrogen priming, patients will be randomized to luteal phase support with a standard formulation (200mg tid, Utrogestan®) or a new formulation (400mg bid) VMP. All patients will undergo a serum P measurement on the day before embryo transfer (ET). Patients with P<10 ng/ml will receive a supplement of oral micronized progesterone 300mg, while patients with P≥10ng/ml will maintain the previous luteal phase support (LPS) protocol

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fundación Santiago Dexeus Font
• Treatments: Progesterone

Criteria

Inclusion Criteria:

• Endometrial preparation with hormone replacement therapy

• Age 18-43 years following an autologous IVF cycle (with or without preimplantation genetic testing for aneuploidy)

• Age < 50 years following an egg donation cycle

• BMI > 18 and < 30 kg/m2

• blastocyst embryo transfer

• Willing to participate in the study

• Able to come to the Center to comply with the procedures of the study: blood tests, appointments and drug dispensation.

Exlusion Criteria:

• • Uterine diseases (e.g. submucosal fibroids, polyps, previously diagnosed Müllerian abnormalities)

• Hydrosalpinx

• Recurrent pregnancy loss (≥ 3 previous miscarriages)

• Recurrent implantation failure (≥ 3 previously failed embryo transfers of good-quality blastocysts)

• Allergy to study medication

• Pregnancy or lactation

• Contraindication for hormonal treatment

• Personalized initiation of exogenous progesterone according to a previous endometrial receptivity assay test

• Recent history of severe disease requiring regular treatment (clinically significant concurrent medical condition that could compromise subject safety or interfere with the trial assessment).