Surgical Ovarian Drilling Versus Hormonal Treatment for Infertility Associated to PolyCystic Ovaries Syndrome (PCOS)
- Conditions
- Polycystic Ovary Syndrome
- Interventions
- Drug: Metformin and FSHrProcedure: Ovarian drilling by FERTILOSCOPY
- Registration Number
- NCT00378729
- Lead Sponsor
- Assistance Publique - Hôpitaux de Paris
- Brief Summary
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
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%).
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 252
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A Metformin and FSHr - B Ovarian drilling by FERTILOSCOPY -
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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 Evaluation of tolerance during the study Body Mass Index with each visit at each visit
Trial Locations
- Locations (1)
Hopital Antoine Beclere
🇫🇷Clamart, France