A Phase III randomized controlled trial comparing the efficacy, safety and tolerability of two formulations of vaginal micronized progesterone.
- Conditions
- infertilityTherapeutic area: Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13]
- Registration Number
- CTIS2024-513102-57-00
- Lead Sponsor
- Santiago Dexeus Font Fundacio Privada
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 1020
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).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method