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

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

Overview[ - collapse ][ - ]

Purpose	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
Condition	Polycystic Ovary Syndrome
Intervention	Drug: Metformin and FSHr Procedure: Ovarian drilling by FERTILOSCOPY
Phase	Phase 4
Sponsor	Assistance Publique - Hôpitaux de Paris
Responsible Party	Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier	NCT00378729
First Received	September 19, 2006
Last Updated	October 3, 2011
Last verified	October 2007

Tracking Information[ + expand ][ + ]

First Received Date	September 19, 2006
Last Updated Date	October 3, 2011
Start Date	October 2006
Estimated Primary Completion Date	October 2011
Current Primary Outcome 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] [Designated as safety issue: Yes]
Current Secondary Outcome Measures	Evaluation of tolerance [Time Frame: during the study] [Designated as safety issue: Yes] Occurrence of multiple pregnancies [Time Frame: at the end of the study] [Designated as safety issue: Yes] Duration of the menstrual cycles and hormonal ovarian dosages [Time Frame: during the study] [Designated as safety issue: No] Occurrence of spontaneous miscarriages [Time Frame: at the end of the study] [Designated as safety issue: No] Body Mass Index with each visit [Time Frame: at each visit] [Designated as safety issue: No]

Descriptive Information[ + expand ][ + ]

Brief Title	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
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%).
Study Type	Interventional
Study Phase	Phase 4
Study Design	Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Condition	Polycystic Ovary Syndrome
Intervention	Drug: Metformin and FSHr treatment for infertility Other Names: treatment for infertilityProcedure: Ovarian drilling by FERTILOSCOPY surgical ovarian drilling Other Names: surgical ovarian drilling
Study Arm (s)	Active Comparator: A Active Comparator: B

Recruitment Information[ + expand ][ + ]

Recruitment Status	Recruiting
Estimated Enrollment	252
Estimated Completion Date	October 2011
Estimated Primary Completion Date	October 2011
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 - 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	Female
Ages	18 Years
Accepts Healthy Volunteers	No
Contacts	Contact: Hervé FERNANDEZ, MD,PhD +33(0)- 1 45 37 44 69 herve.fernandez@abc.aphp.fr
Location Countries	France

Administrative Information[ + expand ][ + ]

NCT Number	NCT00378729
Other Study ID Numbers	P051008
Has Data Monitoring Committee	Yes
Information Provided By	Assistance Publique - Hôpitaux de Paris
Study Sponsor	Assistance Publique - Hôpitaux de Paris
Collaborators	Hopital Antoine Beclere Hôpital Jean Verdier Jean Rostand Intercommoned Hospital Centre Hospitalier Universitaire, Amiens University Hospital, Caen University Hospital, Clermont-Ferrand Lille Hospital : Jeanne de Flandre Hospital Strasbourg Hospital : Civil Hospital SIHCUS-CMCO (Schiltigheim) Study and research center of sterility (Lyon)
Investigators	Principal Investigator: Hervé FERNANDEZ, MD,PhD Assistance Publique - Hôpitaux de Paris
Verification Date	October 2007

Locations[ + expand ][ + ]