In Vitro Fertilization Outcomes of Two Treatment Protocols in Women With Polycystic Ovary Syndrome

Study Overview
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Brief Summary
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Outcomes of IVF/ICSI cycles of women with PCOS undergoing Gonadotropin Releasing Hormone (GnRH) agonist and GnRH Antagonist fixed protocol.

Detailed Description
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Women with PCOS undergoing IVF/ICSI cycles will be evaluated by two different protocols. One arm of the study includes oral contraceptive plus GnRH agonist protocol with 150 IU FSH (standard dose) and second arm includes oral contraceptive plus GnRH Antagonist with 150 IU FSH dose and fixed 6th day starting of GnRH Antagonist.

Official Title
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IVF/ICSI Outcomes of OCP Plus GnRH Agonist Protocol Versus OCP Plus GnRH Antagonist Fixed Protocol in Women With PCOS

Conditions
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PCOS GnRH Antagonist and GnRH Agonist IVF/ICSI Cycles

Intervention / Treatment
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* Other: To compare the IVF/ICSI outcomes of GnRH Antagonist cycle versus GnRH agonist cycle
* Other: GnRH Antagonist


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: PCOS women undergoing ICSI cycles All women will be administered 150 IU rec FSH Exclusion Criteria: Women having other endocrinopathies women older than 35 third IVF/ICSI cycles previous and current use of metformin

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 35 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

Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: GnRH Agonist<br>oral contraceptive pill and GnRH Agonist IVF/ICSI cycle | Other: To compare the IVF/ICSI outcomes of GnRH Antagonist cycle versus GnRH agonist cycle<br>* 150 IU FSH dose and OCP plus GnRH Agonist (long luteal) IVF/ICSI cycle and 150 IU FSH dose and OCP plus GnRH Antagonist (Fixed protocol) IVF/ICSI Cycle<br>|
| Active Comparator: GnRH Agonist Arm<br>Oral contraceptive pill and day 21 GnRH agonist began, Day 3 of menstruation 150 IU FSH will be started. If 3 or more follicle reach >17 mm hCG will be administered. | Other: To compare the IVF/ICSI outcomes of GnRH Antagonist cycle versus GnRH agonist cycle<br>* 150 IU FSH dose and OCP plus GnRH Agonist (long luteal) IVF/ICSI cycle and 150 IU FSH dose and OCP plus GnRH Antagonist (Fixed protocol) IVF/ICSI Cycle<br>Other: GnRH Antagonist<br>* GnRH Antagonist cycle; 150 IU FSH and sixth day Antagonist will be administered<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ongoing pregnancy rates | Ongoing pregnancy rates measured in OCP plus GnRH Agonist and OCP plus GnRH Antagonist cycles in women with PCOS | March 2009 to June 2011 | 
| clinical pregnancy rate | To evaluate the clinical pregnancy rates of both study arms | from march 2009 to july 2011 | 
| Total gonadotropin use | Total gonadotropin use of both study arms | From march 2009 to June 2011 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OHSS rates | OHSS rates in both study groups | from march 2009 to july 2011 | 
| Total ongoing pregnancy rate | Total ongoing pregnacy rates of per protocol group including freezing-thawing embryo transfer cycles. | from march 2009 to june 2011 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PCOS, IVF/ICSI, Clinical Pregnancy rates, GnRH Antagonist, GnRH Agonist