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Clinical trial

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

ID
Name
2206-MAD-089-SC
Description
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.
Trial arms
Trial start
2023-12-15
Estimated PCD
2024-06-01
Trial end
2024-12-31
Status
Active (not recruiting)
Phase
Early phase I
Treatment
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.
Arms:
Study group: Oral administration of letrozole
Other names:
Oral administration of letrozole
Size
152
Primary endpoint
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.
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 152, 'type': 'ESTIMATED'}}
Updated at
2024-02-16

1 organization

1 product

1 indication

Organization
IVI Madrid
Product
Letrozole
Indication
Luteinized Follicular Cyst