IVF Versus Gonadotropin Therapy in Women With CC Resistant PCOS

Study Overview
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Brief Summary
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The purpose of this study is to compare the efficacy of in vitro fertilization (IVF) versus gonadotropin therapy in infertile women having clomiphene citrate (CC) resistant polycystic ovarian syndrome (PCOS).

Detailed Description
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Women will be randomly divided into two groups; IVF group and gonadotropin group. Women in the IVF group will undergo one full IVF cycle. Women in the gonadotropin group will be subjected to ovarian stimulation for 6 months with the gonadotropin low-dose step-down protocol.

Official Title
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In Vitro Fertilization Versus Gonadotropin Therapy in Women With Clomiphene Citrate Resistant Polycystic Ovarian Syndrome

Conditions
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Infertility, Polycystic Ovarian Syndrome

Intervention / Treatment
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* Procedure: IVF
* Drug: Gonadotropin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Infertile women with PCOS as defined by the Rotterdam criteria. CC resistance (defined as failure of ovulation after receiving 150 mg/day of CC for 5 consecutive days per cycle, for at least 3 consecutive cycles). Exclusion Criteria: Age < 20 or > 35 years. Presence of any infertility factor other than anovulatory PCOS. Previous history of ovarian surgery or surgical removal of one ovary. Previous exposure to cytotoxic drugs or pelvic irradiation. Oral hypoglycemic or hormonal therapy either currently or in the preceding 3 months. Metabolic or hormonal abnormalities.

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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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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: IVF group<br>Women will undergo one full IVF cycle | Procedure: IVF<br>* Women will undergo one IVF cycle<br>* Other names: Intracytoplasmic sperm injection (ICSI);|
| Active Comparator: Gonadotropin group<br>Women will be subjected to ovarian stimulation for 6 months with the gonadotropin low-dose step-down protocol. | Drug: Gonadotropin<br>* Women will be subjected to ovarian stimulation for 6 months with the gonadotropin low-dose step-down protocol<br>* Other names: Human Menopausal Gonadotropin (HMG);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Live birth rate | Number of live births divided by the number of women | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical pregnancy rate | Number of clinical pregnancies divided by the number of women | 6-8 weeks gestational age | 
| Multifetal pregnancy rate | Number of multifetal pregnancies divided by the number of clinical pregnancies | 12 weeks gestational age | 
| Miscarriage rate | Number of first trimester miscarriages (before 12 weeks gestational age) divided by the number of clinical pregnancies | 12 weeks gestational age | 
| Incidence of early ovarian hyperstimulation syndrome (OHSS) | Incidence of OHSS within 9 days of final triggering of oocyte maturation | Within 9 days of final triggering of oocyte maturation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IVF, PCOS, Clomiphene citrate resistant, Gonadotropin