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

Phase 1

Not yet recruiting

• Conditions: Progesterone Elevation; Premature Luteinisation
• Interventions: Other: GnRH antagonist

• Registration Number: NCT05759871
• Lead Sponsor: National and Kapodistrian University of Athens

Brief 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.

Study Timeline

• Status Verified: 2023-02
• Study First Submitted: 2023-02-09
• Study First Submitted QC: 2023-02-26
• Study First Posted: 2023-03-08
• Last Update Submitted: 2023-03-08
• Last Update Posted: 2023-03-10
• Study Start: 2023-04-01
• Primary Completion: 2024-03-01
• Study Completion: 2024-07-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FSH only (no GnRH antagonist)	GnRH antagonist	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.
FSH + GnRH antagonist	GnRH antagonist	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.

Primary Outcome Measures

Name	Time	Method
Rate of concentration of progesterone >1 ng/ml	At any time within 3 weeks after start of ovarian stimulation.	Concentration of progesterone elevation \>1 ng/ml
Rate of LH secretory peaks	3 weeks after start of ovarian stimulation.	A secretory peak of LH is defined as the increase at levels ≥10 IU/l.

Secondary Outcome Measures

Name	Time	Method
Rate of ongoing clinical pregnancy	12 weeks after last menstrual period	Clinical pregnancy (fetal heart beat) at ultrasound
Rate of miscarriage	Within 20 weeks after last menstrual period	Miscarriage / Loss of the embryo