Study of Mechanisms of Anovulation in Polycystic Ovary Syndrome (SOPK)
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.
Drug: usual administration of exogenous recombinant FSH
|Study Design:||Observational Model: Defined Population
Time Perspective: Longitudinal
|Official Title:||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|
|Study Start Date:||November 2003|
|Study Completion Date:||January 2007|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00492882
|Hôpital Jeanne de Flandre - C.H.R.U.|
|LILLE Cedex, France, 59037|
|Study Chair:||Didier R DEWAILLY, MD||University Hospital of Lille|