Comparison Between GnRH Agonist and GnRH Antagonist Protocols of Ovarian Stimulation in PCOS Patients

Study Overview
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Brief Summary
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The purpose of this study is to compare pregnancy rates and the occurrence of OHSS in PCOS patients who were treated with GnRH agonist and GnRH antagonist protocols ovarian stimulation during an IVF cycle. Our hypothesis is that the GnRH antagonist protocol reduces the occurrence and severity of OHSS compared to the GnRH agonist protocol.

Detailed Description
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Women with polycystic ovarian syndrome (PCOS) represent a group of patients at high risk of developing ovarian hyperstimulation syndrome (OHSS), an iatrogenic complication of ovarian stimulation during IVF treatment. In contrast to mild OHSS, severe OHSS is a life-threatening complication, characterized by massive ovarian enlargement, ascites, pleural effusion, oliguria, haemoconcentration and thromboembolic phenomena. Currently, no curative therapy for OHSS is available and thus prevention is considered the most effective treatment. Several measures have been adopted to reduce the occurrence of the syndrome, the most effective being cycle cancellation and withholding of human chorionic gonadotropin (hCG), which seems to be the most critical factor for the development of OHSS. COMPARISON: This study aims to compare the development and severity of OHSS, as well as ongoing pregnancy rates in PCOS patients who received a flexible GnRH antagonist (Ganirelix) protocol vs a long GnRH agonist (Arvekap) protocol of ovarian stimulation.

Official Title
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Randomized Controlled Trial Comparing the Effect of GnRH Agonist and Antagonist Ovarian Stimulation Protocols in PCOS Patients

Conditions
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Polycystic Ovary Syndrome, Ovarian Hyperstimulation Syndrome

Intervention / Treatment
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* Drug: Arvekap 0.1mg (Triptorelin, Ipsen, France)
* Drug: Ganirelix 0.25mg (Orgalutran, Organon, The Netherlands)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of PCOS (presence of oligo-ovulation/anovulation and polycystic ovaries) Exclusion Criteria: Normal responders Poor responders

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Arvekap 0.1mg (Triptorelin, Ipsen, France)|nan|
|Drug: Ganirelix 0.25mg (Orgalutran, Organon, The Netherlands)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Development of OHSS |  |  | 
| Ongoing pregnancy rate per embryo transfer |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biochemical pregnancy |  |  | 
| Clinical pregnancy |  |  | 
| Embryological data |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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OHSS, PCOS, GnRH antagonist, GnRH agonist