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.
Status | Completed |
Enrollment | 188 |
Est. completion date | December 2014 |
Est. primary completion date | December 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 25 Years to 40 Years |
Eligibility |
Inclusion Criteria: - 25 to 40 y - infertile - submitted to IVF - no hormonal disease - normal FSH (< 10) - anti-mullerian hormone (AMH) > 1 ng and < 10 ng - both ovaries - only first or second IVF Exclusion Criteria: - thyroid-stimulating hormone (TSH), prolactin (PRL) altered - endometrioma - ovarian tumor or cysts - previous Ovarian Hyperstimulation Syndrome (OHSS) - severe male factor |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Brazil | Centro de Reproduçao Humana Insemine | Porto Alegre | RGS |
Lead Sponsor | Collaborator |
---|---|
Hospital de Clinicas de Porto Alegre | Center for Human Reproduction |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Embryo quality - score of embryo quality in the model od the Graduated Embryo Score (GES) | The embryo evaluation will be performed on day three after fertilization based on the Graduated Embryo Score (GES). It will be performed three evaluations occurring at 16 - 18 hours, 25 - 27 hours and 64 - 67 hours post insemination, by the same embryologist (DS) The score is composed by the following criteria: nucleolar alignment along pronuclear axis, regular cleavage and degree of fragmentation at the first cell division, and cell number and morphology on day 3 after fertilization. The score ranges from 20 to 100 per embryo. | 3 to 5 days after the ovarian punction | No |
Secondary | number of follicles graduated by size in groups of 13-14mm; 15-16mm and more than 17mm | 10 to 13 days after the IVF protocol starts | No | |
Secondary | total number of units of gonadotrophins used to ovarian stimulation | 10 to 13 days after the IVF protocol starts | No | |
Secondary | number of oocytes retrieved (MII) | 10 to 13 days after the IVF protocol starts | No | |
Secondary | number of embryos | 3 to 5 days after the ovarian punction | No |
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