Effects of Letrozole During the Luteal Phase After Controlled Ovarian Stimulation in Oocyte Donors.
Recruiting
Phase 3
Interventional Study
Luteinised Follicular Cyst
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
At a Glance
- Age
- 18 – 34
- Sex
- Female
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 152 (estimated)
- Sponsor
- IVI Madrid · Other
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About This 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 speci…
Trial Locations
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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, tha…
Contacts