Ignite Creation Date:
2024-05-06 @ 6:38 PM
Last Modification Date:
2024-10-26 @ 2:52 PM
Study NCT ID:
NCT05738382
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-07-27
First Post:
2023-01-28
Brief Title:
Efficacy and Safety of BG2109 During Controlled Ovarian Hyperstimulation in Female Subjects Undergoing ART Procedures
Sponsor:
Bio Genuine Shanghai Biotech Co Ltd
Organization:
Bio Genuine Shanghai Biotech Co Ltd
Study Overview
Official Title:
A Randomized Double-blind Open for Active Comparator Parallel Multi-center Phase II Study to Explore the Efficacy Safety and Tolerability of BG2109 Compared With Cetrorelix During COH in Female Subjects Undergoing ART Procedures
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-07
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:
To explore the optimal effective daily dose of BG2109 to suppress premature luteinizing hormone LH surge during COH in female subjects undergoing ART procedures
Detailed Description:
This study is a randomized double-blind open for active comparator parallel multi-center phase II dose-finding clinical study to explore the efficacy safety and tolerability of different doses of BG2109 compared with Cetrorelix during Controlled Ovarian Hyperstimulation COH in Chinese female subjects undergoing Assisted Reproductive Technology ART procedures
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