CTIS2024-513102-57-00
Recruiting
Phase 1
A Phase III randomized controlled trial comparing the efficacy, safety and tolerability of two formulations of vaginal micronized progesterone. - FSD-MIC-2022-03
Santiago Dexeus Font Fundacio Privada0 sites1,020 target enrollmentApril 8, 2024
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- infertility
- Sponsor
- Santiago Dexeus Font Fundacio Privada
- Enrollment
- 1020
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion 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.
Exclusion 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).
Outcomes
Primary Outcomes
Not specified
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