Ignite Creation Date:
2024-05-06 @ 7:28 PM
Last Modification Date:
2024-10-26 @ 3:07 PM
Study NCT ID:
NCT06023602
Status:
RECRUITING
Last Update Posted:
2024-07-10
First Post:
2023-08-18
Brief Title:
Effectiveness of Generic Versus Reference Cetrorelix Acetate for Ovarian Stimulation Using a Gonadotropin-releasing HormoneGnRHAntagonist Protocol in Women Undergoing IVF
Sponsor:
Northwest Womens and Childrens Hospital Xian Shaanxi
Organization:
Northwest Womens and Childrens Hospital Xian Shaanxi
Study Overview
Official Title:
Effectiveness of Generic Cetrorelix Acetate Versus Reference Cetrorelix Acetate for Ovarian Stimulation Using a GnRH Antagonist Protocol in Women Undergoing IVF A Multicenter Non-inferiority Randomised Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-07
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:
The goal of this clinical trial is to compare the clinical outcomes using different cetrorelix acetate in the context of a GnRH antagonist protocol for ovarian stimulation in women undergoing IVF or intracytoplasmic sperm injectionICSI treatmentThe main question it aims to answer is whether the generic cetrorelix acetate is non-inferior to the reference product in the GnRH antagonist based protocol for women undergoing IVF Ovarian stimulation was achieved by several types of follicle-stimulating hormoneFSH or by FSH combined with luteinizing hormone activity Daily dose of generic cetrorelix acetate 025 mg SC or original cetrorelix acetate 025 mg SC will be administered when the lead follicle was 14 mm When more than two follicles reached 17 mm oocyte maturation was triggered with 250 mcg of recombinant human chorionic gonadotropin
Detailed Description:
None
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?:
False
Is an FDA AA801 Violation?:
None