RecruitingPhase 3NCT06244745

Effects of Letrozole During the Luteal Phase After Controlled Ovarian Stimulation 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


Sponsor

IVI Madrid

Enrollment

152 participants

Start Date

Dec 15, 2023

Study Type

INTERVENTIONAL

Conditions

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: FEMALEMin Age: 18 YearsMax Age: 34 Years

Inclusion Criteria1

  • 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 Criteria3

  • 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.

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Interventions

DRUGAdministration 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.


Locations(1)

IVI-Madrid

Madrid, Spain

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NCT06244745