Surgical Ovarian Drilling Versus Hormonal Treatment for I... | NCT00378729

Status Module

Record Verification Date

Oct 2007

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2006

Primary Completion Date

Oct 2011Estimated

Completion Date

Oct 2011Estimated

First Submitted Date

Sep 19, 2006

First Submission Date that Met QC Criteria

Sep 19, 2006

First Posted Date

Sep 21, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 3, 2011

Last Update Posted Date

Oct 4, 2011Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sponsor

Lead Sponsor

Assistance Publique - Hôpitaux de ParisOTHER

Collaborators

Name	Class
Hopital Antoine Beclere	OTHER
Hôpital Jean Verdier	OTHER
Jean Rostand Intercommoned Hospital	UNKNOWN
Centre Hospitalier Universitaire, Amiens

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Conditions Module

Conditions

Polycystic Ovary Syndrome

Keywords

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

252Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A	Active Comparator		Drug: Metformin and FSHr
B	Active Comparator		Procedure: Ovarian drilling by FERTILOSCOPY

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Metformin and FSHr	Drug	treatment for infertility	A	treatment for infertility

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Evaluation of the cumulative rate of on-going pregnancy (>12 weeks of amenorrhoea) obtained during 9 months of follow-up		during 9 months of follow-up

Secondary Outcomes

Measure	Description	Time Frame
Evaluation of tolerance		during the study
Occurrence of multiple pregnancies		at the end of the study
Duration of the menstrual cycles and hormonal ovarian dosages

Other Outcomes

Not provided

Eligibility Module

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<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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

36 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

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

Overall Officials

Name	Affiliation	Role
Hervé FERNANDEZ, MD,PhD	Assistance Publique - Hôpitaux de Paris	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hopital Antoine Beclere	Recruiting	Clamart		92170	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
15559352	Background	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. doi: 10.1016/s1074-3804(05)60054-0.

ID	Term
D010048	Ovarian Cysts
D003560	Cysts
D009369	Neoplasms
D010049	Ovarian Diseases
D000291	Adnexal Diseases
D005831	Genital Diseases, Female
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D000091662	Genital Diseases
D006058	Gonadal Disorders
D004700	Endocrine System Diseases

ID	Term
D008687	Metformin
D013812	Therapeutics

ID	Term
D001645	Biguanides
D006146	Guanidines
D000578	Amidines
D009930	Organic Chemicals