Ignite Creation Date:
2025-12-24 @ 9:18 PM
Ignite Modification Date:
2026-01-03 @ 12:31 PM
Study NCT ID:
NCT02412904
Status:
COMPLETED
Last Update Posted:
2015-08-21
First Post:
2013-11-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Randomized Controlled Trial Comparing Embryonic Quality in rFSH Versus hMG in IVF Protocol With GnRH Antagonist
Sponsor:
Hospital de Clinicas de Porto Alegre
Organization:
Study Overview
Official Title:
Phase 4 Study Comparing Recombinant Follicle Stimulating Hormone (rFSH) or Ultra-pure to HMG in Patients Submitted to IVF Using Gnrh Antagonist
Status:
COMPLETED
Status Verified Date:
2015-08
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:
rFSH and HMG are both used to controlled ovarian stimulation for patients submitted to IVF. However, there is a debate in the literature which one is better to induce ovulation in patients receiving GnRH antagonist to block premature Luteinizing Hormone (LH) secretion.
The investigators propose a Randomized Clinical Trial (RCT) to investigate the differences among recombinant FSH and HMG in patients submitted to IVF using GnRH antagonists.
The investigators propose a Randomized Clinical Trial (RCT) to investigate the differences among recombinant FSH and HMG in patients submitted to IVF using GnRH antagonists.
Detailed Description:
To compare embryonic quality and other clinical outcomes when using human menopause gonadotropin (hMG) or recombinant follicle stimulating hormone (rFSH) to the ovarian stimulation in IVF cycles with the GnRH antagonist protocol.
Design: open randomized single center study with infertile patients submitted to IVF comparing IVF outcomes between hMG and rFSH when controlled with GnRH antagonist.
Setting: A single private center of reproductive medicine in association with Universidade Federal do Rio Grande do Sul.
Patients: Infertile women with normal ovarian reserve with IVF indication. Intervention: The patients were randomized in two groups, 85 received rFSH and 83 received hMG to ovulation induction, both groups used GnRH antagonist to prevent ovulation.
Main Outcome Measure: Total embryonic score and best embryonic score. Secondary outcomes: Total dose of gonadotropins, number and size of follicles in the end of the stimulation, number of mature oocytes, number of embryos, pregnancy rates.
Design: open randomized single center study with infertile patients submitted to IVF comparing IVF outcomes between hMG and rFSH when controlled with GnRH antagonist.
Setting: A single private center of reproductive medicine in association with Universidade Federal do Rio Grande do Sul.
Patients: Infertile women with normal ovarian reserve with IVF indication. Intervention: The patients were randomized in two groups, 85 received rFSH and 83 received hMG to ovulation induction, both groups used GnRH antagonist to prevent ovulation.
Main Outcome Measure: Total embryonic score and best embryonic score. Secondary outcomes: Total dose of gonadotropins, number and size of follicles in the end of the stimulation, number of mature oocytes, number of embryos, pregnancy rates.
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?: