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

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

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: April 2010

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

10%).

Intervention(s) in this Clinical Trial

• Drug: Metformin and FSHr
  • treatment for infertility
• Procedure: Ovarian drilling by FERTILOSCOPY
  • surgical ovarian drilling

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: A
• Active Comparator: B

Primary Measures

• Evaluation of the cumulative rate of on-going pregnancy (>12 weeks of amenorrhoea) obtained during 9 months of follow-up
  • Time Frame: during 9 months of follow-up
    Safety Issue?: Yes

Secondary Measures

• Evaluation of tolerance
  • Time Frame: during the study
    Safety Issue?: Yes
• Occurrence of multiple pregnancies
  • Time Frame: at the end of the study
    Safety Issue?: Yes
• Duration of the menstrual cycles and hormonal ovarian dosages
  • Time Frame: during the study
    Safety Issue?: No
• Occurrence of spontaneous miscarriages
  • Time Frame: at the end of the study
    Safety Issue?: No
• Body Mass Index with each visit
  • Time Frame: at each visit
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 36 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Overall Clinical Trial Officials and Contacts

Hervé FERNANDEZ, MD,PhD Principal Investigator Assistance Publique - Hôpitaux de Paris  

Overall Contact: Hervé FERNANDEZ, MD,PhD +33(0)- 1 45 37 44 69 herve.fernandez@abc.aphp.fr

Information obtained from ClinicalTrials.gov on September 04, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00378729

Study ID Number: P051008

ClinicalTrials.gov Identifier: NCT00378729

Health Authority: France: Ministry of Health