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

Condition(s) targeted: Polycystic Ovary Syndrome

Intervention: Metformin and FSHr (Drug); Ovarian drilling by FERTILOSCOPY (Procedure)

Phase: Phase 4

Status: Recruiting

Sponsored by: Assistance Publique - Hôpitaux de Paris

Official(s) and/or principal investigator(s):
Hervé FERNANDEZ, MD,PhD, Principal Investigator, Affiliation: Assistance Publique - Hôpitaux de Paris

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

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

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Evaluation of the cumulative rate of on-going pregnancy (>12 weeks of amenorrhoea) obtained during 9 months of follow-up

Secondary outcome:

Evaluation of tolerance

Occurrence of multiple pregnancies

Duration of the menstrual cycles and hormonal ovarian dosages

Occurrence of spontaneous miscarriages

Body Mass Index with each visit

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%).

Minimum age: 18 Years. Maximum age: 36 Years. Gender(s): Female.

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

- 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

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

Hopital Antoine Beclere, Clamart 92170, France; Recruiting
Hervé FERNANDES, MD,PhD, Phone: +33(0)- 1 45 37 44 69, Email: herve.fernandez@abc.aphp.fr
Hervé FERNANDEZ, MD, Principal Investigator

Related publications:

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.

Starting date: October 2006
Last updated: October 3, 2011