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Status unknownNCT00378729PERCINGUpdated Oct 4, 2011

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

A Phase 4 interventional study of Metformin and FSHr and Ovarian drilling by FERTILOSCOPY in Polycystic Ovary Syndrome, sponsored by Assistance Publique - Hôpitaux de Paris. Status unknown at 1 site in France. Open to female participants aged 18 Years to 36 Years. Per ClinicalTrials.gov, last updated 2011-10-04.

Sponsored by Assistance Publique - Hôpitaux de Paris · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2007), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
252
Allocation
Randomized
Ages
18 Years to 36 Years
Sex
Female
01

Study 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

Read the 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%).

02

Conditions studied

  • 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
03

In context

Polycystic Ovary Syndrome

944 studies on the registry are indexed under Polycystic Ovary Syndrome; 174 are open to participants now.

This study's planned enrollment of 252 is above the median of 70 across 685 interventional studies indexed under Polycystic Ovary Syndrome.

Browse Polycystic Ovary Syndrome studies →

Lead sponsor

Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 36 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
252 participants (estimated)

Study arms

  • Active comparator
    A

    Drug: Metformin and FSHr

  • Active comparator
    B

    Procedure: Ovarian drilling by FERTILOSCOPY

Interventions

  • DrugMetformin and FSHr

    treatment for infertility

    Also known as: treatment for infertility

  • ProcedureOvarian drilling by FERTILOSCOPY

    surgical ovarian drilling

    Also known as: surgical ovarian drilling

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. Evaluation of tolerance

    Time frame: during the study

  2. Occurrence of multiple pregnancies

    Time frame: at the end of the study

  3. Duration of the menstrual cycles and hormonal ovarian dosages

    Time frame: during the study

  4. Occurrence of spontaneous miscarriages

    Time frame: at the end of the study

  5. Body Mass Index with each visit

    Time frame: at each visit

07

Study locations

1 of 1 sites recruiting
  • Hopital Antoine Beclere
    Clamart, 92170, France
    • Hervé FERNANDES, MD,PhD · Contact · herve.fernandez@abc.aphp.fr · +33(0)- 1 45 37 44 69
    • Hervé FERNANDEZ, MD · Principal investigator
    Recruiting
08

References and documents

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. doi: 10.1016/s1074-3804(05)60054-0. PubMed 15559352 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 4, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00378729
Lead 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, University Hospital, Strasbourg, France, CMCO SIHCUS, Schiltingheim, Study and research center of sterility (Lyon)
Responsible party
Sponsor
First posted
Sep 21, 2006
Start date
Oct 2006
Primary completion
Oct 2011 (estimated)
Completion
Oct 2011 (estimated)
Last update
Oct 4, 2011

Study contacts

Hervé FERNANDEZ, MD,PhD
Contact
herve.fernandez@abc.aphp.fr
+33(0)- 1 45 37 44 69
Hervé FERNANDEZ, MD,PhD
principal investigator · Assistance Publique - Hôpitaux de Paris

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Oct 2007. You cannot join it, but the record below documents what was studied.

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