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

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.

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.

Inclusion Criteria:

• healthy women 21-32 years old with a BMI of 21 to 29 kg/m2 who wish to donate their oocytes

• normal ovarian reserve tests

• normal menstrual cycles of 26-32 days

• the women would not have received any hormonal treatment during the last three months before entering the study.

  • absence of coagulation and/or autoimmune disorders.

Exclusion Criteria:

1. Use of other protocols towards oocyte retrieval, such as natural, or modified natural cycles

2. Poor ovarian response according to the Bologna criteria [22],

3. History of endocrine or metabolic disorders, ovarian cystectomy or oophorectomy,

4. Women with the diagnosis of polycystic ovary syndrome

5. Clinical and/or laboratory markers of hereditary or acquired thrombophilia that complied to the standard protocols of each Unit.

   • Non-hormonal medication for a serious medical condition