Surgical Ovarian Drilling Versus Hormonal Treatment for Infertility Associated to PolyCystic Ovaries Syndrome (PCOS)

Study Overview
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Brief Summary
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PolysCsytic Ovaries Syndrome (PCOS) is the most frequent endocrinopathy. The first stage of infertility treatment is Clomiphene Citrate which leads to 50 % pregnancies. In case of failure, it is possible to propose surgical ovarian drilling or ovarian hyperstimulation with Intra Uterine Insemination (IUI) which lead to 50% pregnancies each. However, surgical treatment could be associated to surgical complications, and medical treatment could be associated to ovarian hyperstimulation syndrome and/or multiple pregnancies. The aim of this study is to compare the two treatments to demonstrate the equivalence of efficacy and the diminution of multiple pregnancies by the surgical treatments. After an ambulatory surgery we will observe the spontaneous fertility during 9 months. For the medical treatment, Metformin is proposed during 9 months associated with 3 cycles of ovarian hyperstimulation and IUI if the sperm is normal

Detailed Description
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PolysCsytic Ovaries Syndrome (PCOS) is the most frequent endocrinopathy. The first stage of infertility treatment is Clomiphene Citrate which leads to 50 % pregnancies. In case of failure, it is possible to propose surgical ovarian drilling or ovarian hyperstimulation with Intra Uterine Insemination (IUI) which lead to 50% pregnancies each. However, surgical treatment could be associated to surgical complications, and medical treatment could be associated to ovarian hyperstimulation syndrome and/or multiple pregnancies. The aim of this study is to compare the two treatments to demonstrate the equivalence of efficacy and the diminution of multiple pregnancies by the surgical treatments. After an ambulatory surgery we will observe the spontaneous fertility during 9 months. For the medical treatment, Metformin is proposed during 9 months associated with 3 cycles of ovarian hyperstimulation and IUI if the sperm is normal Ovarian drilling will be performed by FERTILOSCOPY. 126 patients will be necessary in each group (with interval of equivalence : 10%).

Official Title
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PERCING : Ovarian Drilling Versus Ovarian Stimulation + Intra Uterine Insemination (IUI) + Metformin in the PCOS (PolyCystic Ovaries Syndrome) Treatment

Conditions
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Polycystic Ovary Syndrome

Intervention / Treatment
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* Drug: Metformin and FSHr
* Procedure: Ovarian drilling by FERTILOSCOPY


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 18 and 36 years old Female patient with PCOS (Rotterdam criteria) Failure of treatment with Clomiphene Citrate Informed consent Female patient with medical assurance Patient in failure with PCOS and Clomiphene citrate Exclusion Criteria: Female patient is over 36 years old Thyroid disease (4<TSH<0.3 mUI/L) Virilizing tumor FERTILOSCOPY non possible (Douglas cul de sac clinically fixed) Anormality of SPERMOGRAM (abnormal time of migration of survival) Prolactin > 1.5 N Anormality of 17-OH Progesterone (<2 ng/mL) Fallopian tubes non permeable TMS< 5 Millions Female patient participant or have been participated to another clinical trial during the last month before the inclusion Female patient without medical assurance

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 36 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: A<br> | Drug: Metformin and FSHr<br>* treatment for infertility<br>* Other names: treatment for infertility;|
| Active Comparator: B<br> | Procedure: Ovarian drilling by FERTILOSCOPY<br>* surgical ovarian drilling<br>* Other names: surgical ovarian drilling;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the cumulative rate of on-going pregnancy (>12 weeks of amenorrhoea) obtained during 9 months of follow-up |  | during 9 months of follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of tolerance |  | during the study | 
| Occurrence of multiple pregnancies |  | at the end of the study | 
| Duration of the menstrual cycles and hormonal ovarian dosages |  | during the study | 
| Occurrence of spontaneous miscarriages |  | at the end of the study | 
| Body Mass Index with each visit |  | at each visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PCOS, FERTILOSCOPY, Ovarian hyperstimulation, Multiple pregnancies, Patient with PCOS (Rotterdam criteria), Failure of treatment with Clomiphene Citrate, Age between 18 and 36 years old, Spermogram must be normal, Permeability of Fallopian tubes