Ignite Creation Date:
2024-05-05 @ 5:36 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00492882
Status:
COMPLETED
Last Update Posted:
2007-06-27
First Post:
2007-06-26
Brief Title:
Study of Mechanisms of Anovulation in Polycystic Ovary Syndrome
Sponsor:
University Hospital Lille
Organization:
University Hospital Lille
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2003-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SOPK
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 expressionIn 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 US parameters will be assessed twice a week until 3 days after appearance of 1 dominant folliclesThe starting dose of recFSH will be 50 IUday In the absence of criteria for dominance see below after 14 days at 50 IUday recFSH dose will be increased by 25 IUday 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 mmday and serum E2 100 pgL Ultrsound examination will performed with a 7-MHz transvaginal transducer Sonoline Elegra Siemens in real time according to a standardized protocolSerum AMH levels will be assessed using the second-generation enzyme immunoassay AMH-EIA
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None