Using letrozole to reduce ovarian volume in oocyte donors
Clinical and Endocrinological Effects of Letrozole During the Luteal Phase After Controlled Ovarian Stimulation in Oocyte Donors: a Low Interventional, Randomized, Controlled Trial
This study is testing if the medication letrozole can help reduce the size of the ovaries in women donating eggs and see how it affects their hormone levels.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 152 (estimated) |
| Ages | 18 Years to 34 Years |
| Sex | Female |
| Sponsor | IVI Madrid Academic / other |
| Locations | 1 site (Madrid) |
| Trial ID | NCT06244745 on ClinicalTrials.gov |
What this trial studies
This trial investigates the effects of letrozole during the luteal phase in oocyte donors to determine if it can reduce ovarian volume and affect the duration of the luteal phase. Participants will be randomly assigned to either a control group receiving no treatment or a study group receiving letrozole for five days following follicular puncture. The study will assess hormonal and biochemical markers to evaluate the drug's efficacy and safety in this context. The goal is to provide insights into managing hyper-responsiveness in oocyte donors.
Who should consider this trial
Good fit: Ideal candidates are oocyte donors who exhibit hyper-responsiveness to stimulation, characterized by having 18 or more follicles of a certain size prior to ovarian puncture.
Not a fit: Patients with known allergies to letrozole or lactose intolerance may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could help minimize discomfort and risks associated with ovarian hyperstimulation in oocyte donors.
How similar studies have performed: While letrozole has been used in various reproductive contexts, the specific application in this study is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Hyper-responsiveness to stimulation, defined as the presence of ≥18 follicles of size ≥11 mm (22-24) on the day of the last ultrasound visit prior to ovarian puncture. Exclusion Criteria: * Participation in another clinical study, prior to inclusion in the present study, that could affect the objectives of this study. * Known allergy to letrozole. * Known lactose intolerance.
Where this trial is running
Madrid
- IVI-Madrid — Madrid, Spain (Recruiting)
Study contacts
- Principal investigator: Sergio Caballero, PhD — Ivirma Madrid
- Study coordinator: Sergio Caballero, PhD
- Email: sergio.caballero@ivirma.com
- Phone: +34 91 180 29 00
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.