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

May 20, 2025 updated by: IVI Madrid

Clinical and Endocrinological Effects of Letrozole During the Luteal Phase After Controlled Ovarian Stimulation in Oocyte Donors: a Low Interventional, Randomized, Controlled Trial

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Letrozole is a widely used drug in the context of hormone-dependent malignant tumors due to its antiestrogenic effect. Its mechanism of action allows its application to the field of Assisted Reproductive Medicine, mainly as an inductor of ovulation, by means of a blockage in the negative feedback signalization of the hypothalamus-pituitary-gonadal axis. In the last years, it has also been tested with the goals of preventing ovarian hyperstimulation syndrome (OHSS) or analyzing its effects on several endocrinological and biochemical markers such as LH, progesterone or VEGF. However, the results are inconsistent on every account. Data regarding the effect on ovarian size and the duration of the luteal phase following the administration of letrozole after the oocyte pick-up can be useful to evaluate the benefit of this drug in patients with a tendency towards hyperresponse, in which both the discomfort after the stimulation and the risk of ovarian torsion are increased.

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

Study Type

Interventional

Enrollment (Estimated)

152

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Spain
      • Madrid, Spain, 28023
        • Recruiting
        • IVI-Madrid
        • Contact:
          • Juan A Garcia-Velasco, MD, PhD
          • Phone Number: 3491 1802900
          • Email: jgvelasco@ivi.es
        • Principal Investigator:
          • Juan A Garcia-Velasco, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study group: Oral 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. day for 5 days starting the night of the follicular puncture.
Drug: 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.
Other Names:
  • Oral administration of letrozole
No Intervention: Control group: No specific treatment of letrozole
No specific treatment with letrozol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 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
On the day of ovarian puncture, 5 days post-puncture and 10 days post-puncture.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: On the day of ovarian puncture, 5 days post-puncture and 10 days post-puncture.
To determine the difference of plasma values of VEGF, sFlt-1, oestradiol, progesterone, FSH, LH and testosterone. Ratio VEGF/sFlt-1. Continuous numerical variables.
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.
Time Frame: On the day of ovarian puncture and 10 days post-puncture.
To determine the difference of duration of the luteal phase, inferred by the number of days from follicular puncture to the start of the next menstrual cycle. onset of the next menstrual cycle. Discrete numerical variable.
On the day of ovarian puncture and 10 days post-puncture.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IVI Madrid

Investigators

  • Principal Investigator: Sergio Caballero, PhD, IVIRMA MADRID

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 15, 2023

Primary Completion (Actual)

May 1, 2025

Study Completion (Estimated)

May 31, 2025

Study Registration Dates

First Submitted

January 11, 2024

First Submitted That Met QC Criteria

February 5, 2024

First Posted (Actual)

February 6, 2024

Study Record Updates

Last Update Posted (Actual)

May 21, 2025

Last Update Submitted That Met QC Criteria

May 20, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2206-MAD-089-SC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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