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

NCT06244745 | Recruiting Phase 3 DMC

• 1 other identifier: 2206-MAD-089-SC
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 1

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.

Conditions

Luteinised Follicular Cyst

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  On the day of ovarian puncture, 5 days post-puncture and 10 days post-puncture.

Secondary Outcomes (2)

• To determine the levels of VEGF, VEGF/sFlt-1 ratio, LH, FSH, oestradiol, progesterone and testosterone in the plasma of oocyte donors depending on whether or not they receive the study treatment during the luteal phase.

  On the day of ovarian puncture, 5 days post-puncture and 10 days post-puncture.

• To determine the duration of the luteal phase in oocyte donors depending on whether or not they receive the treatment under study during the luteal phase after ovarian stimulation.

  On the day of ovarian puncture and 10 days post-puncture.

Study Arms (2)

Study group: Oral administration of letrozole

EXPERIMENTAL

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. day for 5 days starting the night of the follicular puncture.

Drug: Administration of letrozole

Control group: No specific treatment of letrozole

NO INTERVENTION

No specific treatment with letrozol

Interventions

Administration of letrozole DRUG

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.

Also known as: Oral administration of letrozole

Study group: Oral administration of letrozole

Eligibility Criteria

• Age: 18 Years - 34 Years
• Gender Eligibility Details: Women who have been accepted into IVI's oocyte donation programme
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Known allergy to letrozole.
• Known lactose intolerance.

Sponsors & Collaborators

• IVI Madrid: lead

Study Sites (1)

IVI-Madrid

Madrid, 28023, Spain

RECRUITING

Study Officials

• Sergio Caballero, PhD

  IVIRMA MADRID

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sergio Caballero, PhD

CONTACT

+34 91 180 29 00; sergio.caballero@ivirma.com

Juan Antonio Garcia Velasco, PhD

CONTACT

+34 91 180 29 00; juan.garcia.velasco@ivirma.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2024
• First Posted: February 6, 2024
• Study Start: December 15, 2023
• Primary Completion: May 1, 2025
• Study Completion: May 31, 2025
• Last Updated: May 21, 2025

Record last verified: 2025-02

Locations

ES (1)