Infertility Clinical Trial
Official title:
Phase 4 Study Comparing Recombinant Follicle Stimulating Hormone (rFSH) or Ultra-pure to HMG in Patients Submitted to IVF Using Gnrh Antagonist
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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