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New treatment option for Infertility
Official title MIcronized PROgesterone in Frozen Embryo Transfer Cycles
ClinicalTrials.gov ID: NCT05899010
What this study is testing
What is Vaginal progesterone 600mg daily?
Vaginal progesterone 600mg daily is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for infertility.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 50, women only
You may be able to join if
- 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
See the full eligibility 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).
The study team makes the final eligibility decision.
Where it's taking place
- Barcelona, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 50 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Barcelona, Spain. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.