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

Assistance Publique - Hôpitaux de Paris

Status and phase: Unknown; Phase 4

Conditions: Polycystic Ovary Syndrome

Treatments: Drug: Metformin and FSHr; Procedure: Ovarian drilling by FERTILOSCOPY

Study type: Interventional

Funder types: Other

Identifiers

NCT00378729

P051008

Details and patient eligibility

About

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

Full 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%).

Enrollment: 252 estimated patients

Sex: Female

Ages: 18 to 36 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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252 participants in 2 patient groups

A

Active Comparator group

Treatment:

Drug: Metformin and FSHr

B

Active Comparator group

Treatment:

Procedure: Ovarian drilling by FERTILOSCOPY