Clinical trial NCT00378729: Surgical Ovarian Drilling Versus Hormonal Treatment for Infertility Associated to PolyCystic Ovaries Syndrome (PCOS)
Official title: PERCING : Ovarian Drilling Versus Ovarian Stimulation + Intra Uterine Insemination (IUI) + Metformin in the PCOS (PolyCystic Ovaries Syndrome) Treatment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Polycystic Ovary Syndrome
Keywords: 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
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Hopital Antoine Beclere
name: Hôpital Jean Verdier
name: Jean Rostand Intercommoned Hospital
name: Centre Hospitalier Universitaire, Amiens
name: University Hospital, Caen
name: University Hospital, Clermont-Ferrand
name: Lille Hospital : Jeanne de Flandre Hospital
name: University Hospital, Strasbourg, France
name: CMCO SIHCUS, Schiltingheim
name: Study and research center of sterility (Lyon)
First posted: 2006-09-21
Enrollment: 252
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 36
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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%).

Eligibility criteria: 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

Primary outcomes:
measure: Evaluation of the cumulative rate of on-going pregnancy (>12 weeks of amenorrhoea) obtained during 9 months of follow-up
timeFrame: during 9 months of follow-up
Secondary outcomes:
measure: Evaluation of tolerance
timeFrame: during the study
measure: Occurrence of multiple pregnancies
timeFrame: at the end of the study
measure: Duration of the menstrual cycles and hormonal ovarian dosages
timeFrame: during the study
measure: Occurrence of spontaneous miscarriages
timeFrame: at the end of the study
measure: Body Mass Index with each visit
timeFrame: at each visit
Other outcomes:
Locations:
city: Clamart
country: France
facility: Hopital Antoine Beclere
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Hervé FERNANDEZ, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fernandez H, Watrelot A, Alby JD, Kadoch J, Gervaise A, deTayrac R, Frydman R. Fertility after ovarian drilling by transvaginal fertiloscopy for treatment of polycystic ovary syndrome. J Am Assoc Gynecol Laparosc. 2004 Aug;11(3):374-8. doi: 10.1016/s1074-3804(05)60054-0.