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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


Phase 4
18 Years
40 Years
Not Enrolling
Female
Anovulation

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Trial Information

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


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.


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

Type of Study:

Observational

Study Design:

Observational Model: Defined Population, Observational Model: Natural History, Time Perspective: Longitudinal, Time Perspective: Prospective

Principal Investigator

Didier R DEWAILLY, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University Hospital of Lille

Authority:

France: Institutional Ethical Committee

Study ID:

CP03/102

NCT ID:

NCT00492882

Start Date:

November 2003

Completion Date:

January 2007

Related Keywords:

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

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