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A Phase III randomized controlled trial comparing the efficacy, safety and tolerability of two formulations of vaginal micronized progesterone.
EU CTIS ID: 2024-513102-57-00
What this study is testing
To compare the ongoing pregnancy rate following luteal phase support with standard formulation (200mg tid) and a new formulation (400mg bid) vaginal micronized progesterone in patients undergoing an AC-FET.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- patients undergoing an artificial cycle-frozen embryo transfer (AC-FET)
- 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
You likely can't join if
- 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
See the full eligibility criteria
- patients undergoing an artificial cycle-frozen embryo transfer (AC-FET)
- 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.
- 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.
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, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.