Use of r-hLH (Luveris) in Donors Previously Treated With r-hFSH (Gonal F)
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
研究概览
地位
干预/治疗
详细说明
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.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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New Jersey
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Morristown、New Jersey、美国、07960
- Reproductive Medicine Assoicates of New Jersey
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Age less than or equal to 32 years old
- BMI<35
- 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
Exclusion Criteria:
- 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
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：非随机化
- 介入模型：交叉作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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其他：r-hFSH (Gonal F)
Patients will be treated with r-hFSH throughout the stimulation phase of their first cycle until r-hCG administration.
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r-hFSH dose to be determined by the patient's primary doctor and adjusted according to their response
其他名称：
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其他：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.
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Patients will begin r-hLH at 300IU/day when there are 2 follicles greater than or equal to 14mm.
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Safety and efficacy of r-hFSH protocol
大体时间：6 months
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Evaluation of the safety and efficacy of r-hFSH for controlled ovarian stimulation in the same patients.
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6 months
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Safety and efficacy of r-hFSH + r-hLH protocol
大体时间：6 months
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Evaluation of the safety and efficacy of r-hFSH for controlled ovarian stimulation in the same patients.
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6 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Number of oocytes retrieved
大体时间：6 months
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Evaluation of the number of oocytes obtained as a function of stimulation protocol.
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6 months
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Quality of embryos obtained
大体时间：6 months
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Evaluation of pregnancy rates (clinical and ongoing), delivery rates, multiple pregnancy rates and the number of cancelled cycles.
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6 months
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Incidences of ovarian hyperstimulation syndrome
大体时间：6 months
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Evaluation of the potential adverse effects associated with ovarian stimulation
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6 months
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Quality of oocytes obtained
大体时间：6 months
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Evaluation of the quality of oocytes obtained as a function of stimulation protocol.
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6 months
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合作者和调查者
调查人员
- 首席研究员：Richard T Scott, MD、Reproductive Medicine Associates of New Jersey
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
r-hFSH的临床试验
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Merck KGaA, Darmstadt, Germany完全的
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Merck KGaA, Darmstadt, GermanyMerck Serono S.P.A., Italy终止
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Merck KGaA, Darmstadt, GermanyMerck Pte. Ltd., Singapore完全的
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Merck KGaA, Darmstadt, GermanyMerck, S.L., Spain终止
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Centro Riproduzione e Andrologia完全的