Clinical trial NCT05899010: MIcronized PROgesterone in Frozen Embryo Transfer Cycles
Official title: A Phase III Randomized Controlled Trial Comparing the Efficacy, Safety and Tolerability of Two Formulations of Vaginal Micronized Progesterone
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Infertility
Lead sponsor: Fundacion Dexeus
Sponsor class: OTHER
First posted: 2023-06-12
Enrollment: 1020
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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


Eligibility 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).

Primary outcomes:
measure: Ongoing pregnancy rate
timeFrame: 7-9 weeks after embryo transfer
Secondary outcomes:
measure: Implantation rate
timeFrame: 3-4 weeks after embryo transfer
measure: Biochemical pregnancy rate
timeFrame: 10 to 12 days after embryo transfer
measure: Clinical pregnancy rate
timeFrame: 3-4 weeks after embryo transfer
measure: Miscarriage rate
timeFrame: before completion of 12 weeks of gestation
measure: Frequency of adverse events
timeFrame: Until 15 days after the end of treatment with progesterone
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Universitario Quiron Dexeus
Study officials:
affiliation: Service of Reproductive Medicine Dexeus University Hospital
name: Nikolaos P Polyzos, MD, PhD
role: STUDY_CHAIR
affiliation: Service of Reproductive Medicine Dexeus University Hospital
name: Noemie Sachs-Guedj, MD
role: PRINCIPAL_INVESTIGATOR
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