Effect of Progesterone Levels on Pregnancy Outcomes in Infertile Women
Impact of Serum Progesterone Levels on the Day of β-hCG Test in Artificial Cycles on the Ongoing Pregnancy Rate.
This study is testing if lower progesterone levels on the day of a pregnancy test can lead to more miscarriages in women undergoing fertility treatments.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 900 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | Female |
| Sponsor | Instituto Valenciano de Infertilidad, IVI VALENCIA Academic / other |
| Locations | 1 site (Valencia, Valencia) |
| Trial ID | NCT05750849 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the relationship between serum progesterone levels on the day of the β-hCG test and ongoing pregnancy rates in women undergoing artificial cycles. It includes a prospective cohort of infertile patients who receive luteal phase support with vaginal natural progesterone. The study aims to determine if lower serum progesterone levels on the day of the pregnancy test correlate with higher miscarriage rates, despite positive pregnancy tests. The goal is to identify a cut-off point for progesterone levels that could predict pregnancy outcomes.
Who should consider this trial
Good fit: Ideal candidates are women under 50 years old with a BMI of 35 or less and adequate endometrial thickness.
Not a fit: Patients with uterine or adnexal pathology or systemic diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help optimize progesterone supplementation strategies to improve pregnancy outcomes for women undergoing artificial cycles.
How similar studies have performed: Previous studies have indicated a correlation between serum progesterone levels and pregnancy outcomes, suggesting this approach has been explored but may still hold novel insights.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * The subject must provide written informed consent prior to any study related procedures * Women ≤50 years old * BMI ≤ 35 kg/m2 * Adequate endometrial thickness (\>6.5mm) and pattern (Triple A structure) in the proliferative phase Exclusion Criteria: * Uterine Pathology, adnexal pathology * Systemic diseases
Where this trial is running
Valencia, Valencia
- IVI RMA Valencia — Valencia, Valencia, Spain (Recruiting)
Study contacts
- Study coordinator: Laura Caracena, Msr
- Email: LAURA.CARACENA@IVIRMA.COM
- Phone: 034 963 050 900
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.