NCT05759871

Ovarian Stimulation With FSH Alone Versus FSH Plus GnRH Antagonist in an Oocyte Donor/Recipient Programme

Ovarian Stimulation With FSH Alone Versus FSH Plus a GnRH Antagonist in an Oocyte Donor/Recipient Programme: a Protocol for a Non-randomised Multicenter Study

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: National and Kapodistrian University of Athens · Academic / Other
• Sex: Female
• Age: 21 Years – 32 Years
• Healthy volunteers: Accepted

Summary

The aim of this study is to compare the efficacy of a protocol using FSH alone with that of a protocol using FSH plus a GnRH antagonist for controlled ovarian hyperstimulation in cycles of elective freezing in the context of a donor/recipient programme.

Detailed description

The hypothesis to be tested is that an ovarian stimulation protocol that includes FSH alone without any LH surge prevention regimens is not inferior to a protocol including FSH plus a GnRH antagonist in terms of clinical outcome in a donor/recipient model. The formal sample size is calculated as follows: If there is a true difference in favour of the experimental treatment of 5% (20% vs 15%), then 160 patients (80 per group in case of 1:1 enrolment) are required to be 80% sure that the upper limit of a one-sided 95% confidence interval (or equivalently a 90% two-sided confidence interval) will exclude a difference in favour of the standard/control group of more than 10%. In the context of the present pilot study (as a first stage), the investigators intend to study 50 patients (25 per group in case of 1:1 enrolment). At a second stage the above mentioned sample size will be used.

Conditions

• Premature Luteinisation
• Progesterone Elevation

Interventions

Type	Name	Description
OTHER	GnRH antagonist	The GnRH antagonist in the control group (standard therapy) is administered from day 6 of FSH treatment at the dose of 0.25 mg per day until the triggering day and is injected each time immediately after the injection of FSH.

Timeline

• Start date: 2023-04-01
• Primary completion: 2024-03-01
• Completion: 2024-07-01
• First posted: 2023-03-08
• Last updated: 2023-03-10