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

Sponsor:	Assistance Publique - Hôpitaux de Paris
Collaborators:	Hopital Antoine Beclere Jean Verdier Hospital (AP-HP) 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)
Information provided by:	Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:	NCT00378729

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	Intervention	Phase
Polycystic Ovary Syndrome	Drug: Metformin and FSHr Procedure: Ovarian drilling by FERTILOSCOPY	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	PERCING : Ovarian Drilling Versus Ovarian Stimulation + Intra Uterine Insemination (IUI) + Metformin in the PCOS (PolyCystic Ovaries Syndrome) Treatment

Resource links provided by NLM:

MedlinePlus related topics: Infertility Surgery

Drug Information available for: Metformin Metformin hydrochloride

U.S. FDA Resources

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

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 ]

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 ]

Estimated Enrollment:	252
Study Start Date:	October 2006
Estimated Study Completion Date:	April 2010
Estimated Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Active Comparator	Drug: Metformin and FSHr treatment for infertility
B: Active Comparator	Procedure: Ovarian drilling by FERTILOSCOPY surgical ovarian drilling

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

Ages Eligible for Study:	18 Years to 36 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00378729

Contacts

Contact: Hervé FERNANDEZ, MD,PhD

+33(0)- 1 45 37 44 69

herve.fernandez@abc.aphp.fr

Locations

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

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Hopital Antoine Beclere

Jean Verdier Hospital (AP-HP)

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

More Information

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.

Responsible Party:	Department Clinical Research of the Developpement ( Christophe AUCAN )
Study ID Numbers:	P051008, AOR 05039
Study First Received:	September 19, 2006
Last Updated:	May 5, 2008
ClinicalTrials.gov Identifier:	NCT00378729 History of Changes
Health Authority:	France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:

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

Additional relevant MeSH terms:

Polycystic Ovary Syndrome
Disease
Gonadal Disorders
Physiological Effects of Drugs
Metformin
Endocrine System Diseases
Ovarian Diseases
Cysts

Pharmacologic Actions
Adnexal Diseases
Genital Diseases, Female
Neoplasms
Hypoglycemic Agents
Pathologic Processes
Syndrome
Ovarian Cysts

ClinicalTrials.gov processed this record on February 08, 2010