NCT06244745 Effects of Letrozole During the Luteal Phase After Controlled Ovarian Stimulation in Oocyte Donors.
| NCT ID | NCT06244745 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | IVI Madrid |
| Condition | Luteinised Follicular Cyst |
| Study Type | INTERVENTIONAL |
| Enrollment | 152 participants |
| Start Date | 2023-12-15 |
| Primary Completion | 2025-05-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 152 participants in total. It began in 2023-12-15 with a primary completion date of 2025-05-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The objective of this trial is to determine whether the use of letrozole during the luteal phase in oocyte donors diminishes the ovarian volume, as well as to evaluate its effect on the duration of the luteal phase, taking into account hormonal and biochemical markers. Two groups will be established with random allocation of patients and 1:1 proportionality, as follows: * Control group: No specific treatment. * Study group: Oral administration of letrozole 5 mg (each capsule is 2.5 mg) once a day for 5 days starting on the night of the follicular puncture.
Eligibility 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.
Contact & Investigator
Sergio Caballero, PhD
PRINCIPAL INVESTIGATOR
IVIRMA MADRID
Frequently Asked Questions
Who can join the NCT06244745 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 34 Years, studying Luteinised Follicular Cyst. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06244745 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 152 participants.
Is NCT06244745 currently recruiting?
Yes, NCT06244745 is actively recruiting participants. Contact the research team at sergio.caballero@ivirma.com for enrollment information.
Where is the NCT06244745 trial being conducted?
This trial is being conducted at Madrid, Spain.
Who is sponsoring the NCT06244745 clinical trial?
NCT06244745 is sponsored by IVI Madrid. The principal investigator is Sergio Caballero, PhD at IVIRMA MADRID. The trial plans to enroll 152 participants.