Phase 4 Study Comparing Recombinant Follicle Stimulating Hormone (rFSH) or Ultra-pure to HMG in Patients Submitted to IVF Using Gnrh Antagonist
概览
- 阶段
- 4 期
- 干预措施
- rFSH
- 疾病 / 适应症
- Infertility
- 发起方
- Hospital de Clinicas de Porto Alegre
- 入组人数
- 188
- 试验地点
- 1
- 主要终点
- Embryo quality - score of embryo quality in the model od the Graduated Embryo Score (GES)
- 状态
- 已完成
- 最后更新
- 10年前
概览
简要总结
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.
详细描述
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.
研究者
入排标准
入选标准
- •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
排除标准
- •thyroid-stimulating hormone (TSH), prolactin (PRL) altered
- •endometrioma
- •ovarian tumor or cysts
- •previous Ovarian Hyperstimulation Syndrome (OHSS)
- •severe male factor
研究组 & 干预措施
drug to ovulation induction: rFSH
Patients submitted to IVF that will use rFSH (Puregon®, Organon Ltd., Ireland) for ovarian stimulation
干预措施: rFSH
drug to ovulation induction :HMG
Patients submitted to IVF that will use hMG (Menopur®, Ferring Pharmaceuticals, Denmark) for ovarian stimulation
干预措施: HMG
结局指标
主要结局
Embryo quality - score of embryo quality in the model od the Graduated Embryo Score (GES)
时间窗: 3 to 5 days after the ovarian punction
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.
次要结局
- 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)
- total number of units of gonadotrophins used to ovarian stimulation(10 to 13 days after the IVF protocol starts)
- number of embryos(3 to 5 days after the ovarian punction)
- number of oocytes retrieved (MII)(10 to 13 days after the IVF protocol starts)