NCT05899010 MIcronized PROgesterone in Frozen Embryo Transfer Cycles
| NCT ID | NCT05899010 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Fundación Santiago Dexeus Font |
| Condition | Infertility |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,020 participants |
| Start Date | 2023-07-05 |
| Primary Completion | 2027-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 1,020 participants in total. It began in 2023-07-05 with a primary completion date of 2027-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
Contact & Investigator
Nikolaos P Polyzos, MD, PhD
STUDY CHAIR
Service of Reproductive Medicine Dexeus University Hospital
Frequently Asked Questions
Who can join the NCT05899010 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 50 Years, studying Infertility. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05899010 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 1,020 participants.
Is NCT05899010 currently recruiting?
Yes, NCT05899010 is actively recruiting participants. Contact the research team at nikpol@dexeus.com for enrollment information.
Where is the NCT05899010 trial being conducted?
This trial is being conducted at Barcelona, Spain.
Who is sponsoring the NCT05899010 clinical trial?
NCT05899010 is sponsored by Fundación Santiago Dexeus Font. The principal investigator is Nikolaos P Polyzos, MD, PhD at Service of Reproductive Medicine Dexeus University Hospital. The trial plans to enroll 1,020 participants.