A Phase 3 interventional study of Administration of letrozole in Luteinised Follicular Cyst, sponsored by IVI Madrid. Recruiting at 1 site in Spain. Open to female participants aged 18 Years to 34 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-21.
Sponsored by IVI Madrid · Phase 3, Interventional, and Treatment
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:
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
67 studies on the registry are indexed under Cysts; 16 are open to participants now.
This study's planned enrollment of 152 is above the median of 48 across 40 interventional studies indexed under Cysts.
Browse Cysts studies →IVI Madrid is the lead sponsor of 35 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
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
No specific treatment with letrozol
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
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
Time frame: On the day of ovarian puncture, 5 days post-puncture and 10 days post-puncture.
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.
To determine the difference of plasma values of VEGF, sFlt-1, oestradiol, progesterone, FSH, LH and testosterone. Ratio VEGF/sFlt-1. Continuous numerical variables.
Time frame: 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.
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.
Time frame: On the day of ovarian puncture and 10 days post-puncture.
Ran from Dec 2023 to primary completion in May 2025, 16 months.
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