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Trial Title:
Effects of Letrozole During the Luteal Phase After Controlled Ovarian Stimulation in Oocyte Donors.
NCT ID:
NCT06244745
Condition:
Luteinised Follicular Cyst
Conditions: Official terms:
Follicular Cyst
Letrozole
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Active, not recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Administration of letrozole
Description:
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.
Arm group label:
Study group: Oral administration of letrozole
Other name:
Oral administration of letrozole
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.
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
Criteria for 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.
Gender:
Female
Gender based:
Yes
Gender description:
Women who have been accepted into IVI's oocyte donation programme
Minimum age:
18 Years
Maximum age:
34 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
IVI-Madrid
Address:
City:
Madrid
Zip:
28023
Country:
Spain
Start date:
December 15, 2023
Completion date:
December 31, 2024
Lead sponsor:
Agency:
IVI Madrid
Agency class:
Other
Source:
IVI Madrid
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06244745
