Gonadotropin-releasing Hormone (GnRH) Antagonist During 3 Days

Study Overview
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Brief Summary
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In this prospective study, the investigators would like to show whether ovarian stimulation with pretreatment of a GnRH antagonist during 3 consecutive days at initiation of the cycle, is possible.

Detailed Description
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A recently accepted study demonstrated that raised progesterone levels can be normalized through administration of a GnRH antagonist during three subsequent days prior to the start of gonadotropin stimulation in a GnRH antagonist protocol. This regimen, after normalisation of the progesterone value, allows controlled ovarian hyperstimulation (COH). Since this regimen is valid in case of elevated progesterone, GnRH antagonists pretreatment may prove to be a valid tool for scheduling IVF treatment in patients with normal progesterone values on day 2 of the cycle. In this prospective randomised trial, the investigators study the impact of administration of a GnRH antagonist during 3 consecutive days at initiation of the cycle.

Official Title
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Administration of a GnRH Antagonist During 3 Days at Initiation of the Cycle: Impact on the Stimulation in IVF/ICSI

Conditions
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Infertility

Intervention / Treatment
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* Drug: ovarian stimulation
* Drug: ovarian stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: < 39 years old on day of randomisation FSH < 12 (in the early follicular phase) Normal ultrasound scan, i.e. presence of both ovaries, without evidence of abnormality within 6 months prior to randomisation. Regular menstrual cycles of 21-35 days, presumed to be ovulatory. BMI between 18 and 29 (both inclusive) 1st or 2nd trial IVF or ICSI Randomisation at out-patient clinic Exclusion Criteria: ≥ 39 years old on day of randomisation Endometriosis ≥ grade 3 PCOS

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 39 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: A<br>Patients undergo a standard treatment with a classical GnRH antagonist protocol. | Drug: ovarian stimulation<br>* rFSH with GnRH antagonists<br>|
| Active Comparator: B<br>Before undergoing a standard protocol for ovarian stimulation, patients in this group receive a pretreatment with GnRH antagonists during 3 consecutive days | Drug: ovarian stimulation<br>* GnRH antagonist, rFSH, GnRH antagonist<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endocrine profile | The purpose is to assess the endocrine profile in each treatment group | up to 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pregnancy rate | The purpose is to study the pregnancy rate in each treatment group | up to 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IVF, ICSI, GnRH antagonist, pretreatment