A Protocol for a Randomized, Controlled Study to Compare the Use of Gonodotropin-releasing Hormone Agonist Triptoreline (Gonapeptyl®) for Luteal Phase Support Versus Natural Luteal Phase in the Insemination Cycles
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 167
- 试验地点
- 1
- 主要终点
- Live birth rate
研究概览
简要总结
This study is a prospective randomized trial with 242 IUI cycles. Patients are randomized in two groups including 121 cycles in each group. A total of 255 cycles in 167 patients are finally recruited. In the first group, the patients will be treated with triptorelin (Gonapeptyl®) in their luteal phase. As for the other group, the patients will undergo the luteal phase without any supportive medication. This study is going to clarify the role of the gonadotropin agonist (triptorelin acetate, Gonapeptyl®) as a luteal phase supporter. The benefit of the treatment is measured by the numbers in the live birth and clinical pregnancy rates.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 43 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •- Patients with ovarian stimulation cycles preparing to insemination
- •Patients with medical ovarian stimulation protocols including GnRH agonist, aromatase inhibitors and different combinations of GnRH agonists and aromatase inhibitors are included
- •Patient's willingness to participate in the study
排除标准
- •- Failure in the ovarian stimulation cycle
- •Failures in executing the insemination
- •Failures in giving the sperm sample
- •Major troubles in sperm parameters leading to an inadequate sample to accomplish intrauterine insemination
- •Patients with primarily planned progesterone luteal support
研究组 & 干预措施
Gonapeptyl
In the intervention group the patient will get the advice to using triptorelin (Gonapeptyl®) in the eight day after the injection of hCG (Pregnyl®) in the insemination cycle.
干预措施: Triptorelin (Drug)
结局指标
主要结局
Live birth rate
时间窗: At possible delivery (about 40 weeks)
次要结局
- Ongoing pregnancy rate(After two weeks)
- Miscarriage rate(During subsequent about 40 weeks of pregnancy)