IVI-Madrid
Madrid, 28023, Spain
Location status: Recruiting
Location contact
Juan A Garcia-Velasco, MD, PhD
CONTACT
Juan A Garcia-Velasco, MD, PhD
PRINCIPAL_INVESTIGATOR
Recruiting
NCT Number: NCT06244745
Effects of Letrozole During the Luteal Phase After Controlled Ovarian Stimulation in Oocyte Donors.
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year–34 year
Sex eligibility
Female
Study type
Interventional
Phase
Phase 3
Primary location
About this study
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
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Administration of letrozole
DrugOral 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
Primary outcomes
-
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
Secondary outcomes
-
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.
-
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.
Study contacts
Contact information is provided by the study sponsor or research team.
Juan Antonio Garcia Velasco, PhD
CONTACT
Sergio Caballero, PhD
CONTACT
Sponsors and collaborators
Lead sponsor
IVI Madrid
Other
Registry information
Official study title
Clinical and Endocrinological Effects of Letrozole During the Luteal Phase After Controlled Ovarian Stimulation in Oocyte Donors: a Low Interventional, Randomized, Controlled Trial
Acronym: LETRODON
Important dates
- Study start
- 2023
- Primary completion
- 2025
- Study completion
- 2025
- First posted
- Feb 6, 2024
- Registry last updated
- May 21, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.