Ignite Creation Date:
2025-12-18 @ 4:29 AM
Ignite Modification Date:
2025-12-23 @ 6:50 PM
Study NCT ID:
NCT00725491
Status:
None
Last Update Posted:
2022-02-03 00:00:00
First Post:
2008-07-28 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Assess the Efficacy and Safety of Ganirelix (Orgalutran®) Treatment in Chinese Women Undergoing Controlled Ovarian Stimulation for in Vitro Fertilization (IVF) or Intra Cytoplasmatic Sperm Injection (ICSI) (Study 38651)(P05703)
Sponsor:
None
Organization:
Study Overview
Official Title:
A Phase III, Multi-center, Open-label, Randomized Study to Assess the Efficacy and Safety of Org 37462 Treatment in Chinese Women Undergoing Controlled Ovarian Stimulation for IVF or ICSI, Using a Long Protocol of Triptorelin as a Reference Treatment.
Status:
None
Status Verified Date:
2022-02
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:
None
Brief Summary:
The primary purpose of this study is to assess that ganirelix is safe and well-tolerated in Chinese women and that a controlled ovarian stimulation (COS) protocol combining recombinant follicle stimulating hormone (recFSH) with ganirelix is efficient in Chinese women undergoing COS for in vitro fertilization (IVF) or intra cytoplasmatic sperm injection (ICSI).
Detailed Description:
None
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?: