Ignite Creation Date:
2024-05-06 @ 8:17 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06321107
Status:
RECRUITING
Last Update Posted:
2024-03-20
First Post:
2024-03-06
Brief Title:
Long-term Follow-up Safety of a Single Injection of GenSci094 for Ovarian Stimulation Using Daily Recombinant FSH as Reference
Sponsor:
Changchun GeneScience Pharmaceutical Co Ltd
Organization:
Changchun GeneScience Pharmaceutical Co Ltd
Study Overview
Official Title:
A Phase IIIII Extension Study Comparing the Long-term Safety of GenSci094 and Gonal-f in Chinese ART Patients
Status:
RECRUITING
Status Verified Date:
2024-02
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 purpose of this study is to evaluate the safety of a single injection of GenSci094 during Controlled Ovarian Stimulation up to 1 year old of the infants from previous studies
Detailed Description:
Two previous RCTs a phase II and phase III studies of GenSci094 one is NCT06091436 investigated if a single injection of GenSci094 was non-inferior to daily treatment with recFSH in initiating multi-follicular growth The two studies followed 12 weeks after embryo transfer This study is a follow-up to the above mentioned RCTs The purpose of this study is to follow-up with participants of the original study to determine the long-term effect a single injection of GenSci094 during Controlled Ovarian Stimulation might have on newborns until they are 1 year old
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None