Ovarian Stimulation Using Recombinant Follicle-stimulating Hormone (FSH) and Gonadotrophin Releasing Hormone (GnRH) Agonist in Alternate Days (Gonapeptyl)
Effect of Ovarian Stimulation Using Recombinant FSH and GHRH Antagonist in Alternate Days on ICSI Outcomes
研究概览
详细说明
Inclusion criteria were as follows: women of good physical and mental health, under 37 years old, with regular menstrual cycles of 25-35 days, normal basal FSH and luteinizing hormone (LH) levels, body mass index (BMI) less than 30 kg/m2, presence of both ovaries and intact uterus, absence of polycystic ovaries, endometriosis, or gynaecological / medical disorders and a negative result in a screening for sexually transmitted diseases.
No patient had received any hormone therapy for at least 60 days preceding the study. Eligible patients who agreed to participate were randomized in two treatment groups. Patients were allocated to a GnRH analogue treatment group according to a computer-generated randomization table.
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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Sao Paulo、巴西、01401-002
- Fertility - Assisted Fertilization Center
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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:
- women of good physical and mental health
- under 37 years old, with regular menstrual cycles of 25-35 days
- normal basal FSH and LH levels
- BMI less than 30 kg/m2
- presence of both ovaries and intact uterus
- absence of polycystic ovaries
- endometriosis, or gynaecological / medical disorders and a negative result in a screening for sexually transmitted diseases
- all patients signed a written informed consent form
- no patient had received any hormone therapy for at least 60 days preceding the study.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:GnRH agonist
Administration of GnRH agonist in alternate days, recombinant FSH and hCG microdose for ovarian stimulation.
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Triptorelin (0.1 mg, Gonapeptyl® Daily; Ferring, Kiel, Germany) in alternate-days from Day 1 of the menstrual cycle until the day of hCG administration.
其他名称:
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有源比较器:GnRH antagonist
Daily administration of GnRH antagonist, recombinant FSH and hCG microdose for ovarian stimulation.
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When patients presented at least two follicles ≥ 14mm upon scan on days 7- 9, GnRH antagonist (cetrorelix, 0.25 mg/day, Cetrotide®; EMD Serono, Inc, Rockland, MA, USA) administration is started and continued until hCG administration.
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 |
大体时间 |
---|---|
cost of treatment
大体时间:One month
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One month
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次要结果测量
结果测量 |
大体时间 |
---|---|
Implantation and pregnancy rates
大体时间:2 months
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2 months
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合作者和调查者
调查人员
- 首席研究员:Luiz Guilherme Maldonado, M.Sc.、Fertility - Assisted Fertilization Center
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
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