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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Premature Luteinisation, Progesterone Elevation

Intervention / Treatment
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* Other: GnRH antagonist


Participation Criteria
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Eligibility Criteria
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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: Use of other protocols towards oocyte retrieval, such as natural, or modified natural cycles Poor ovarian response according to the Bologna criteria [22], History of endocrine or metabolic disorders, ovarian cystectomy or oophorectomy, Women with the diagnosis of polycystic ovary syndrome 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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 32 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FSH only (no GnRH antagonist)<br>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. | Other: GnRH antagonist<br>* 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.<br>|
| Active Comparator: FSH + GnRH antagonist<br>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. | Other: GnRH antagonist<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of ongoing clinical pregnancy | Clinical pregnancy (fetal heart beat) at ultrasound | 12 weeks after last menstrual period | 
| Rate of miscarriage | Miscarriage / Loss of the embryo | Within 20 weeks after last menstrual period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Controlled ovarian stimulation, GnRH antagonist, oocyte donation, LH surge