Flexible GnRH Antagonist vs Flare up GnRH Agonist Protocol in Poor Responders

Study Overview
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Brief Summary
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The purpose of this study is to compare ovulation induction using a flexible GnRH antagonist protocol and flare up GnRH agonist protocol in IVF patients with poor response to ovarian stimulation. Our hypothesis is that the antagonist protocol provides better IVF outcomes compared to the flare up protocol in this group of patients.

Detailed Description
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Poor responders are women who fail to respond effectively to the usual gonadotropin stimulation protocol applied in an IVF cycle. It seems that a diminished ovarian reserve is the principal factor of poor ovarian response. Several strategies have been proposed for the management of poor responders, including flare up GnRH agonist regimens and the GnRH antagonist, which presents a new hope in this group of patients. Comparisons: Poor responder patients (see inclusion criteria) commencing an IVF treatment cyle will receive ovarian stimulation treatment either using a GnRH antagonist (Ganirelix) or flare up agonist (Arvekap) protocol. Primary outcomes compared will be ongoing pregnancy rates in the two treatment groups.

Official Title
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The Flexible GnRH Antagonist Protocol Provides Better Results (IVF Outcomes) Than Flare up GnRH Agonist Protocol in Poor Responders

Conditions
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Infertility, Premature Ovarian Failure

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: regular menstrual cycle 1 or more failed IVF attempts with poor response 5 or fewer oocytes retrieved FSH>12 IU/l on day 3 Exclusion Criteria: PCOS Normal 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of ovarian stimulation, total rFSH used, estradiol, LH and progesterone concentration on hCG day. |  |  | 
| Number of mature oocytes retrieved. |  |  | 
| Number of fertilised oocytes. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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poor responders, GnRH antagonist, GnRH agonist, flare up, short protocol