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Clinical Trials in Spain / NCT06244745
Recruiting Phase 3

Effects of Letrozole During the Luteal Phase After Controlled Ovarian Stimulation in Oocyte Donors.

NCT06244745 · tracked via the Priya Life Science Spain tracker
Sponsor
IVI Madrid
Phase
Phase 3
Started
2023-12-15
Last updated
2025-05-21

Condition(s) studied

Luteinised Follicular Cyst

Investigational drug(s) / intervention(s)

Administration of letrozole

Administration of letrozole: 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.

Study 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

Sex
FEMALE
Min age
18 Years
Max age
34 Years
Healthy volunteers
Accepted
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.

Primary outcome measure(s)

  • To determine ovarian volume in millilitres in oocyte donors according to whether or not they receive the treatment during the luteal phase after ovarian stimulation. — On the day of ovarian puncture, 5 days post-puncture and 10 days post-puncture.
    Difference (in millilitres) in the mean volume of the two ovaries, calculated for each ovary according to the formula for the volume of an ellipsoid

Trial sites (1)

FacilityCityRegionStatus
IVI-Madrid Madrid Spain Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06244745 on ClinicalTrials.gov ↗ ← All trials in Spain