Study of Mechanisms of Anovulation in Polycystic Ovary Syndrome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2003-11-30

Study Completion Date

2007-01-31

Brief Summary

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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

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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.

Conditions

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Anovulation

Keywords

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Polycystic Ovary Syndrome Follicular Arrest Anti-Mullerian Hormone FSH

Study Design

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Observational Model Type

DEFINED_POPULATION

Study Time Perspective

PROSPECTIVE

Interventions

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usual administration of exogenous recombinant FSH

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Principal Investigators

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Didier R DEWAILLY, MD

Role: STUDY_CHAIR

University Hospital of Lille

Locations

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Hôpital Jeanne de Flandre - C.H.R.U.

Lille, , France

Site Status

Countries

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France

References

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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.

Reference Type BACKGROUND

PMID: 1806568 (View on PubMed)

Other Identifiers

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CP03/102

Identifier Type: -

Identifier Source: org_study_id