NCT00492882

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2003

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2003

Completed
3.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 26, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 27, 2007

Completed
Last Updated

May 14, 2026

Status Verified

September 1, 2003

First QC Date

June 26, 2007

Last Update Submit

May 11, 2026

Conditions

Keywords

Polycystic Ovary SyndromeFollicular ArrestAnti-Mullerian HormoneFSH

Interventions

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Jeanne de Flandre - C.H.R.U.

Lille, 59037, France

Location

Related Publications (3)

  • 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.

    PMID: 19361798BACKGROUND
  • 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.

    PMID: 1806568BACKGROUND
  • 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.

MeSH Terms

Conditions

AnovulationPolycystic Ovary Syndrome

Condition Hierarchy (Ancestors)

Ovarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System DiseasesOvarian CystsCystsNeoplasms

Study Officials

  • Didier R DEWAILLY, MD

    University Hospital of Lille

    STUDY CHAIR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 26, 2007

First Posted

June 27, 2007

Study Start

November 1, 2003

Study Completion

January 1, 2007

Last Updated

May 14, 2026

Record last verified: 2003-09

Locations