Surgical Ovarian Drilling Versus Hormonal Treatment for Infertility Associated to PolyCystic Ovaries Syndrome (PCOS)
NCT ID: NCT00378729
Last Updated: 2011-10-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
252 participants
INTERVENTIONAL
2006-10-31
2011-10-31
Brief Summary
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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
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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%).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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A
Metformin and FSHr
treatment for infertility
B
Ovarian drilling by FERTILOSCOPY
surgical ovarian drilling
Interventions
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Metformin and FSHr
treatment for infertility
Ovarian drilling by FERTILOSCOPY
surgical ovarian drilling
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
36 Years
FEMALE
No
Sponsors
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Hopital Antoine Beclere
OTHER
Hôpital Jean Verdier
OTHER
Jean Rostand Intercommoned Hospital
UNKNOWN
Centre Hospitalier Universitaire, Amiens
OTHER
University Hospital, Caen
OTHER
University Hospital, Clermont-Ferrand
OTHER
Lille Hospital : Jeanne de Flandre Hospital
UNKNOWN
University Hospital, Strasbourg, France
OTHER
CMCO SIHCUS, Schiltingheim
OTHER
Study and research center of sterility (Lyon)
UNKNOWN
Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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Hervé FERNANDEZ, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Locations
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Hopital Antoine Beclere
Clamart, , France
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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P051008
Identifier Type: -
Identifier Source: org_study_id