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Study of Mechanisms of Anovulation in Polycystic Ovary Syndrome

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00492882
Acronym
SOPK
Enrollment
30
Registered
2007-06-27
Start date
2003-11-01
Completion date
2007-01-01
Last updated
2026-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anovulation

Keywords

Polycystic Ovary Syndrome, Follicular Arrest, Anti-Mullerian Hormone, FSH

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.

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.

Interventions

DRUGusual administration of exogenous recombinant FSH

Sponsors

University Hospital, Lille
Lead SponsorOTHER
Organon
CollaboratorINDUSTRY

Study design

Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No

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

Countries

France

Contacts

STUDY_CHAIRDidier R DEWAILLY, MD

University Hospital of Lille

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 15, 2026