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MIcronized PROgesterone in Frozen Embryo Transfer Cycles

RecruitingPhase 3Ages 18 Years - 50 YearsFemaleFundación Santiago Dexeus Font
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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).
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What it tests

  • Vaginal progesterone 600mg daily
  • Vaginal progesterone 800mg daily
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Where

1 site
Hospital Universitario Quiron Dexeus
Barcelona, Spain
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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