MIcronized PROgesterone in Frozen Embryo Transfer Cycles (NCT05899010) | Clinical Trial Compass
RecruitingPhase 3
MIcronized PROgesterone in Frozen Embryo Transfer Cycles
Spain1,020 participantsStarted 2023-07-05
Plain-language 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 (EstrogelĀ®) 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, UtrogestanĀ®) 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 Pā„10ng/ml will maintain the previous luteal phase support (LPS) protocol
Who can participate
Age range18 Years ā 50 Years
SexFEMALE
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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:
* ā¢ Uterine diseases (e.g. submucosal fibroids, polyps, previously diagnosed MĆ¼llerian abnormalities)
* Hydrosalpinx
* Recurrent pregnancy loss (ā„ 3 previous miscarriages)
* Recurrent implantation failure (ā„ 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).