Title
Surgical Ovarian Drilling Versus Hormonal Treatment for Infertility Associated to PolyCystic Ovaries Syndrome (PCOS)
PERCING : Ovarian Drilling Versus Ovarian Stimulation + Intra Uterine Insemination (IUI) + Metformin in the PCOS (PolyCystic Ovaries Syndrome) Treatment
Phase
Phase 4Lead Sponsor
University of ParisStudy Type
InterventionalStatus
Unknown statusIndication/Condition
Polycystic Ovary SyndromeIntervention/Treatment
follitropin alfa sitagliptin ...Study Participants
252PolysCsytic 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
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%).
treatment for infertility
surgical ovarian drilling
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
