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Study of Mechanisms of Anovulation in Polycystic Ovary Syndrome (SOPK)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00492882
First Posted: June 27, 2007
Last Update Posted: June 27, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Organon
Information provided by:
University Hospital, Lille
  Purpose
We previously hypothesized that the excess of Anti-Mullerian Hormone (AMH) at the level of ovarian selectable follicles could be involved in the follicular arrest of Polycystic Ovary Syndrome (PCOS), mainly through inhibition of FSH effect on aromatase expression.In this study, we plan to investigate whether a drop in the serum AMH level would be concomitant to the appearance of a dominant follicle induced by administration of mild amounts of exogenous FSH in women with PCOS.

Condition Intervention Phase
Anovulation Drug: usual administration of exogenous recombinant FSH Phase 4

Study Type: Observational
Study Design: Observational Model: Defined Population
Observational Model: Natural History
Time Perspective: Longitudinal
Time Perspective: Prospective
Official Title: Dynamic Changes in the Serum Anti-Müllerian Hormone Level During Low-Dose recFSH Administration Further Support Its Role in the Anovulation of Polycystic Ovary Syndrome

Resource links provided by NLM:


Further study details as provided by University Hospital, Lille:

Enrollment: 30
Study Start Date: November 2003
Study Completion Date: January 2007
Detailed Description:
Women with PCOS (Rotterdam definition) whom anovulation is resistant to clomiphene citrate will receive recombinant FSH using the low-dose step-up protocol during only one cycle. Serum levels of estradiol, AMH, LH, FSH, inhibin B and ultrasound (U/S) parameters will be assessed twice a week until 3 days after appearance of > 1 dominant follicle(s).The starting dose of recFSH will be 50 IU/day. In the absence of criteria for dominance (see below) after 14 days at 50 IU/day, recFSH dose will be increased by 25 IU/day every 7 days until dominance is achieved. Dominance will be defined by the appearance of at least one follicle >10 mm growing at least 2 mm/day and serum E2> 100 pg/L. Ultrsound examination will performed with a 7-MHz transvaginal transducer (Sonoline Elegra, Siemens), in real time, according to a standardized protocol.Serum AMH levels will be assessed using the second-generation enzyme immunoassay AMH-EIA.
  Eligibility

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • normal sperm analysis in the partners and normal hysterosalpingography in all patients
  • PCOS defined by Rotterdam criteria
  • resistance to clomiphene citrate, i.e. no ovulation at 150 mg/day or no pregnancy after 6 ovulatory cycles
  • informed consent before inclusion

Exclusion Criteria:

  • on-going pregnancy
  • age<18 or >40 yr.
  • unability to understand the treatment protocol
  • other medications
  • any co-existent morbid condition contra-indicating a pregnancy
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00492882


Locations
France
Hôpital Jeanne de Flandre - C.H.R.U.
LILLE Cedex, France, 59037
Sponsors and Collaborators
University Hospital, Lille
Organon
Investigators
Study Chair: Didier R DEWAILLY, MD University Hospital of Lille
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00492882     History of Changes
Other Study ID Numbers: CP03/102
First Submitted: June 26, 2007
First Posted: June 27, 2007
Last Update Posted: June 27, 2007
Last Verified: September 2003

Keywords provided by University Hospital, Lille:
Polycystic Ovary Syndrome
Follicular Arrest
Anti-Mullerian Hormone
FSH

Additional relevant MeSH terms:
Polycystic Ovary Syndrome
Anovulation
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases