Use of r-hLH (Luveris) Late Follicular Phase for Controlled Ovarian Stimulation (COS) in Donor Patients Previously Treated With r-hFSH (Gonal F)in a Long Luteal Downregulated Cycle With GnRH Agonist. A Cross-over Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Safety and efficacy of r-hFSH protocol
研究概览
简要总结
The purpose of the study is to compare the safety and efficacy of r-hLH to r-hFSH in the late follicular phase of young women undergoing controlled ovarian stimulation for oocyte donation.
详细描述
While the role of FSH is considered the fundamental driver of folliculogenesis, the role of LH in this process is more controversial. FSH is associated with stimulating growth and recruitment of follicles while LH is associated with the selection of dominant follicles destined for ovulation. We will use an open, prospective, cross-over study to compare the safety and efficacy of two different treatment protocols for controlled ovarian stimulation in egg donors.
20 participants will undergo two cycles of stimulation. The first one will be with r-hFSH though the cycle and the second with r-hFSH then r-hLH. The participants will have 1 month rest cycle between the treatment cycles. r-hFSH doses will be adjusted according to patient response. r-hLH dosing will begin when there are 2 follicles greater than or equal to 14mm in diameter. The does will be 300IU/day and continue until the day of r-hCG administration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 32 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age less than or equal to 32 years old
- •Eligible for controlled ovarian simulation
- •No PCO-type ovaries (PCO by USS image, >2.1 LH;FSH ratio on cycle day 3, insulin resistance, increase of testosterone over free testosterone)
- •Meet all requirements for becoming an egg donor
- •Willingness and ability to participate and comply with study protocol for the duration of the study
- •Baseline FSH<11
排除标准
- •Clinically significant systemic disease
- •Any contraindication to gonadotropin therapy
- •LH:FSH ratio greater than 3
- •Pregnancy in the past 3 months
- •Any medical condition which, in the judgment of the investigator may interfere with the absorption, distribution, metabolism or excretion of the drug
- •Simultaneous participation in another clinical trial
- •Known active substance abuse, including tobacco and alcohol (>10 cigarettes/day)
- •Refusal or inability to comply with protocol
- •Known poor ovarian response
研究组 & 干预措施
r-hFSH (Gonal F)
Patients will be treated with r-hFSH throughout the stimulation phase of their first cycle until r-hCG administration.
干预措施: r-hFSH (Drug)
r-hFSH (Gonal F) and r-hLH (Luveris)
Patients will be treated with r-hFSH only until they have 2 follicles greater than or equal to 14mm. Patients will then bring 300IU/day of r-hLH until r-hCG administration.
干预措施: r-hFSH and r-hLH (Drug)
结局指标
主要结局
Safety and efficacy of r-hFSH protocol
时间窗: 6 months
Evaluation of the safety and efficacy of r-hFSH for controlled ovarian stimulation in the same patients.
Safety and efficacy of r-hFSH + r-hLH protocol
时间窗: 6 months
Evaluation of the safety and efficacy of r-hFSH for controlled ovarian stimulation in the same patients.
次要结局
- Number of oocytes retrieved(6 months)
- Quality of embryos obtained(6 months)
- Incidences of ovarian hyperstimulation syndrome(6 months)
- Quality of oocytes obtained(6 months)