Ignite Creation Date:
2025-12-25 @ 3:43 AM
Ignite Modification Date:
2026-04-08 @ 7:52 AM
Study NCT ID:
NCT00575302
Status:
WITHDRAWN
Last Update Posted:
2010-04-13
First Post:
2007-12-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Optimal Posology of Gonadotrophins in Patients With Insufficient Ovarian Response Due to Age
Sponsor:
Centre Hospitalier Chretien
Organization:
Study Overview
Official Title:
Study of Optimal Posology of Gonadotrophins in Patients With Insufficient Ovarian Response Due to Age
Status:
WITHDRAWN
Status Verified Date:
2010-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
36 cases were included and the 4 centers and they are unable to increase their recruitment to obtain the 400 cases necessary to reach statistical significance.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In In vitro fertilization (IVF) treatment, poor responder patients of more than 38 years old are randomized prospectively into two dosages of gonadotrophins. The outcome of treatment will be analyzed.
Detailed Description:
Women \> 38 years, who had an insufficient response to stimulation with regular (for age) posology of 225 IU of gonadotrophins (urinary or recombinant), in an agonist protocol will be randomized prospectively into 2 groups:
300 IU versus 450 IU of Gonal-f® administered in a short agonist protocol. Insufficient response is defined as: development of ≤ 4 mature follicles (of ≥ 16 mm) at time of hCG administration.
Patient can be eligible for several cycles in same protocol.
300 IU versus 450 IU of Gonal-f® administered in a short agonist protocol. Insufficient response is defined as: development of ≤ 4 mature follicles (of ≥ 16 mm) at time of hCG administration.
Patient can be eligible for several cycles in same protocol.
Study Oversight
Has Oversight DMC:
False
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?: