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PERCING : Ovarian Drilling Versus Ovarian Stimulation + Intra Uterine Insemination (IUI) + Metformin in the PCOS (PolyCystic Ovaries Syndrome) Treatment


Phase 4
18 Years
36 Years
Open (Enrolling)
Female
Polycystic Ovary Syndrome

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Trial Information

PERCING : Ovarian Drilling Versus Ovarian Stimulation + Intra Uterine Insemination (IUI) + Metformin in the PCOS (PolyCystic Ovaries Syndrome) Treatment


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%).


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
- 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

during 9 months of follow-up

Safety Issue:

Yes

Principal Investigator

Hervé FERNANDEZ, MD,PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Assistance Publique - Hôpitaux de Paris

Authority:

France: Ministry of Health

Study ID:

P051008

NCT ID:

NCT00378729

Start Date:

October 2006

Completion Date:

October 2011

Related Keywords:

  • Polycystic Ovary Syndrome
  • 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
  • Polycystic Ovary Syndrome

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