NCT00378729

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
252

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Oct 2006

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 19, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 21, 2006

Completed
10 days until next milestone

Study Start

First participant enrolled

October 1, 2006

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

October 4, 2011

Status Verified

October 1, 2007

Enrollment Period

5 years

First QC Date

September 19, 2006

Last Update Submit

October 3, 2011

Conditions

Polycystic Ovary Syndrome

Keywords

PCOSFERTILOSCOPYOvarian hyperstimulationMultiple pregnanciesPatient with PCOS (Rotterdam criteria)Failure of treatment with Clomiphene CitrateAge between 18 and 36 years oldSpermogram must be normalPermeability of Fallopian tubes

Outcome Measures

Primary Outcomes (1)

  • 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 (5)

  • 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

    during the study

  • Occurrence of spontaneous miscarriages

    at the end of the study

  • Body Mass Index with each visit

    at each visit

Study Arms (2)

A

ACTIVE COMPARATOR
Drug: Metformin and FSHr

B

ACTIVE COMPARATOR
Procedure: Ovarian drilling by FERTILOSCOPY

Interventions

Metformin and FSHrDRUG

treatment for infertility

Also known as: treatment for infertility
A
Ovarian drilling by FERTILOSCOPYPROCEDURE

surgical ovarian drilling

Also known as: surgical ovarian drilling
B

Eligibility Criteria

Age18 Years - 36 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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 without medical assurance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Antoine Beclere

Clamart, 92170, France

RECRUITING

Related Publications (1)

  • 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.

    PMID: 15559352BACKGROUND

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

MetforminTherapeutics

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Study Officials

  • Hervé FERNANDEZ, MD,PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hervé FERNANDEZ, MD,PhD

CONTACT

+33(0)- 1 45 37 44 69herve.fernandez@abc.aphp.fr

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 19, 2006

First Posted

September 21, 2006

Study Start

October 1, 2006

Primary Completion

October 1, 2011

Study Completion

October 1, 2011

Last Updated

October 4, 2011

Record last verified: 2007-10

Locations

FR(1)