MIcronized PROgesterone in Frozen Embryo Transfer Cycles
- Conditions
- Infertility
- Interventions
- Drug: Vaginal progesterone 800mg dailyDrug: Vaginal progesterone 600mg daily
- Registration Number
- NCT05899010
- Lead Sponsor
- Fundación Santiago Dexeus Font
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 1020
- 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).
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Vaginal progesterone 800mg Vaginal progesterone 800mg daily 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. Vaginal progesterone 600mg Vaginal progesterone 600mg daily 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
- Primary Outcome Measures
Name Time Method Ongoing pregnancy rate 7-9 weeks after embryo transfer A positive heart beat at ultrasound after 11-13 weeks of gestation
- Secondary Outcome Measures
Name Time Method Implantation rate 3-4 weeks after embryo transfer Number of gestational sacs over total embryo transfered
Biochemical pregnancy rate 10 to 12 days after embryo transfer positive beta-human chorionic gonadotropin (hCG)
Miscarriage rate before completion of 12 weeks of gestation any spontaneous abortion that occurred after confirmation of clinical pregnancy
Frequency of adverse events Until 15 days after the end of treatment with progesterone Clinical pregnancy rate 3-4 weeks after embryo transfer A positive heart beat at ultrasound
Trial Locations
- Locations (1)
Hospital Universitario Quiron Dexeus
🇪🇸Barcelona, Spain