Study of Mechanisms of Anovulation in Polycystic Ovary Syndrome (SOPK)
May 11, 2026 updated by: University Hospital, Lille
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Observational
Enrollment (Actual)
30
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Lille, France, 59037
- Hôpital Jeanne de Flandre - C.H.R.U.
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Defined Population
- Time Perspectives: Prospective
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Chair: Didier R DEWAILLY, MD, University Hospital of Lille
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Hamilton-Fairley D, Kiddy D, Watson H, Sagle M, Franks S. Low-dose gonadotrophin therapy for induction of ovulation in 100 women with polycystic ovary syndrome. Hum Reprod. 1991 Sep;6(8):1095-9. doi: 10.1093/oxfordjournals.humrep.a137491.
- Desforges-Bullet V, Gallo C, Lefebvre C, Pigny P, Dewailly D, Catteau-Jonard S. Increased anti-Mullerian hormone and decreased FSH levels in follicular fluid obtained in women with polycystic ovaries at the time of follicle puncture for in vitro fertilization. Fertil Steril. 2010 Jun;94(1):198-204. doi: 10.1016/j.fertnstert.2009.03.004. Epub 2009 Apr 9.
- Pigny P, Jonard S, Robert Y, Dewailly D. Serum anti-Mullerian hormone as a surrogate for antral follicle count for definition of the polycystic ovary syndrome. J Clin Endocrinol Metab. 2006 Mar;91(3):941-5. doi: 10.1210/jc.2005-2076. Epub 2005 Dec 20.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2003
Study Completion (Actual)
January 1, 2007
Study Registration Dates
First Submitted
June 26, 2007
First Submitted That Met QC Criteria
June 26, 2007
First Posted (Estimated)
June 27, 2007
Study Record Updates
Last Update Posted (Actual)
May 14, 2026
Last Update Submitted That Met QC Criteria
May 11, 2026
Last Verified
September 1, 2003
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CP03/102
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