A Randomised, Assessor-blind, Parallel Groups, Multi-centre, Exploratory Study Assessing the Impact of Subcutaneous Administration of Degarelix 2.5 mg on Synchronisation of Follicle Cohort Compared to Placebo and Evaluating the Effects of Degarelix 2.5 mg Started in the Mid-luteal or Early Follicular Phase on Endometrial Receptivity Compared to a Fixed Gonadotrophin Releasing Hormone Antagonist Protocol in Oocyte Donors Undergoing Controlled Ovarian Hyperstimulation for Assisted Reproductive Technologies
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 85
- 试验地点
- 4
- 主要终点
- Coefficient of Variation of Follicular Sizes on Stimulation Day 1 (Follicles ≥ 2 mm)
研究概览
简要总结
The main purpose of this clinical research study is to investigate if degarelix can synchronise the growth of the egg sacs in the ovaries and if degarelix has any effect on the lining of the womb.
详细描述
For the primary end-point (data collected on Stimulation Day 1), the study will compare degarelix 2.5 mg administered in the mid-luteal phase to placebo administered in the mid-luteal phase.
After Stimulation Day 1 the placebo group will be split into two groups: a degarelix 2.5 mg follicular group and a ganirelix 0.25 mg group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Degarelix mid-luteal, 2.5 mg
Degarelix 2.5 mg will be injected subcutaneously (SC) 7 days after luteinizing hormone (LH) peak and on Stimulation Day 6. Placebo will be injected SC on Stimulation Day 1.
干预措施: Degarelix mid-luteal, 2.5 mg (Drug)
Placebo
Placebo will be injected subcutaneously (SC) 7 days after luteinizing hormone (LH) peak. Degarelix 2.5 mg will be injected SC on Stimulation Day 1 and Stimulation Day 6.
or Placebo will be injected SC 7 days after LH peak and on Stimulation Day 1. Ganirelix 0.25 mg will be injected SC daily from Stimulation Day 6 until the last stimulation day.
干预措施: Placebo (Drug)
结局指标
主要结局
Coefficient of Variation of Follicular Sizes on Stimulation Day 1 (Follicles ≥ 2 mm)
时间窗: Stimulation Day 1
Explanation of the term "coefficient of variation": The coefficient of variation is a normalized measure of dispersion of a probability distribution.
次要结局
- Frequency of Oocyte Donors With Adequate Secretory Transformation at the Endometrial Histology Evaluation 7 Days After Injection With Human Chorionic Gonadotrophin (hCG)(7 days after hCG injection)