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Completed

NCT Number: NCT00492882

Study of Mechanisms of Anovulation in Polycystic Ovary Syndrome

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

usual administration of exogenous recombinant FSH

Drug

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Collaborators

  • Organon

Registry information

Official study 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

Acronym: SOPK

Important dates

Study start
2003
Study completion
2007
First posted
Jun 27, 2007
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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