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

National and Kapodistrian University of Athens

Status and phase: Not yet enrolling; Phase 2; Phase 1

Conditions: Progesterone Elevation; Premature Luteinisation

Treatments: Other: GnRH antagonist

Study type: Interventional

Funder types: Other

Identifiers

NCT05759871

Non-anta-D

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: Female

Ages: 21 to 32 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

FSH only (no GnRH antagonist)

Experimental group

Description:

Women receive only FSH starting on day 2 of the cycle. The starting dose of FSH is 225-300 IU s.c. for the first 4 days adjusted thereafter according to the ovarian response.

Treatment:

Other: GnRH antagonist

FSH + GnRH antagonist

Active Comparator group

Description:

Women receive 225-300 IU s.c. FSH, and a GnRH antagonist from day 6 of FSH treatment at the dose of 0.25 mg per day until the triggering day. The GnRH antagonist in group 2 is injected each time immediately after the injection of FSH.

Treatment:

Other: GnRH antagonist