MIcronized PROgesterone in Frozen Embryo Transfer Cycles (MI-PROF)

Fundación Santiago Dexeus Font

Status and phase: Enrolling; Phase 3

Conditions: Infertility

Treatments: Drug: Vaginal progesterone 800mg daily; Drug: Vaginal progesterone 600mg daily

Study type: Interventional

Funder types: Other

Identifiers

NCT05899010

2022-001045-21 (EudraCT Number)

FSD-MIC-2022-03

Details and patient eligibility

About

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

Enrollment: 1,020 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,020 participants in 2 patient groups

Vaginal progesterone 600mg

Active Comparator group

Description:

Vaginal progesterone 600mg daily (200mg tid) will be started and maintained until 10 weeks of pregnancy or either up to menses or up to negative pregnancy test performed 10 days after ET

Treatment:

Drug: Vaginal progesterone 600mg daily

Vaginal progesterone 800mg

Experimental group

Description:

Vaginal progesterone 800mg daily (400mg bid) will be started and maintained until 10 weeks of pregnancy or either up to menses or up to negative pregnancy test performed 10 days after ET.

Treatment:

Drug: Vaginal progesterone 800mg daily