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CompletedNCT00492882SOPKUpdated May 14, 2026

Study of Mechanisms of Anovulation in Polycystic Ovary Syndrome

An observational study in Anovulation, sponsored by University Hospital, Lille. Completed at 1 site in France. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2026-05-14.

Sponsored by University Hospital, Lille · Observational

Study type
Observational
Time perspective
Prospective
Enrollment
30
Ages
18 Years to 40 Years
Sex
Female
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Study summary

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.

Read the 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.

02

Conditions studied

  • Anovulation

Keywords

  • Polycystic Ovary Syndrome
  • Follicular Arrest
  • Anti-Mullerian Hormone
  • FSH
03

In context

Anovulation

75 studies on the registry are indexed under Anovulation; 7 are open to participants now.

This study's enrollment of 30 is below the median of 300 across 17 observational studies indexed under Anovulation.

Browse Anovulation studies →

Lead sponsor

University Hospital, Lille is the lead sponsor of 631 studies on the registry; 142 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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
  • before inclusion

Exclusion criteria

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

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05

Study design

Time perspective
Prospective
Enrollment
30 participants (actual)

Interventions

  • Drugusual administration of exogenous recombinant FSH
06

Study locations

1 site
  • Hôpital Jeanne de Flandre - C.H.R.U.
    Lille, 59037, France
07

References and documents

Publications

  • 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. PubMed 19361798 ↗
  • 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. PubMed 1806568 ↗
  • 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. PubMed 16368745 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00492882
Collaborators
Organon
Responsible party
Sponsor
First posted
Jun 27, 2007
Start date
Nov 2003
Completion
Jan 2007
Last update
May 14, 2026

Study contacts

Didier R DEWAILLY, MD
study chair · University Hospital of Lille

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2003. You cannot join it, but the record below documents what was studied.

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