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

This study has been completed.
Sponsor:
Collaborator:
Organon
Information provided by:
University Hospital, Lille
ClinicalTrials.gov Identifier:
NCT00492882
First received: June 26, 2007
Last updated: NA
Last verified: September 2003
History: No changes posted
  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:

U.S. FDA Resources

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

Ages Eligible for Study:   18 Years to 40 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: June 26, 2007
Last Updated: June 26, 2007
Health Authority: France: Institutional Ethical Committee

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

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

ClinicalTrials.gov processed this record on June 18, 2013