An Exploratory Study to Evaluate a Mixed Protocol of Menopur (Highly Purified Human Menopausal Gonadotropin) and REKOVELLE (Follitropin Delta) for Controlled Ovarian Stimulation in IVF (in Vitro Fertilization)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 160
- 试验地点
- 8
- 主要终点
- Evaluate the number of utilizable blastocysts on Day 5 or Day 6 of embryo culture
研究概览
简要总结
This study proposes to evaluate the effect of adding HP-hMG (Menopur) to follitropin delta in a "mixed protocol" regimen, using an individualized, fixed dose of follitropin delta based on the established algorithm, combined with a variable, adjustable dose of Menopur based on body weight and ovarian reserve.
详细描述
The initial dose of follitropin delta will be determined at enrolment by the analysis of serum AMH on days 2 to 5 of the menstrual cycle preceding the IVF treatment cycle and body weight in Kg The initial dose of HP-hMG to be added on top of follitropin delta will be determined at enrolment by the total follitropin delta dose and body weight in Kg
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women 18 to 40 years of age undergoing their first IVF/ICSI cycle
- •Diagnosed with unexplained infertility, tubal infertility, endometriosis stage I/II, or with partners diagnosed with male factor infertility
- •Regular menstrual cycles of 24-35 days
- •Presence of both ovaries
- •Early follicular phase FSH serum concentration <10 IU/L measured between Day 2 to Day 5 of menstrual cycle within the previous 12 months
- •Ejaculated sperm (fresh or frozen) for insemination
排除标准
- •Inability to consent
- •Endometriosis stage III and IV
- •High risk of OHSS (AMH ≥ 35 pmol/L)
- •History of recurrent miscarriages defined as ≥ 3 consecutive losses
- •Women undergoing egg donation
- •Women participating in any other research project
- •Use of hormonal preparations (except for thyroid medication) during the last menstrual cycle
- •Hypersensitivity to follitropin delta and/or HP-hMG
研究组 & 干预措施
Follitropin delta and HP-hMG
Follitropin delta combined with highly purified human menopausal gonadotrophin
干预措施: Follitropin delta and HP-hMG (Combination Product)
结局指标
主要结局
Evaluate the number of utilizable blastocysts on Day 5 or Day 6 of embryo culture
时间窗: 6 days of embryo culture
Utilizable blastocyst is defined as embryo at day 5 or 6 suitable for transfer
次要结局
- Determine dosage of REKOVELLE and Menopur in a mixed protocol(up to 20 days)
- Evaluate the safety profile of the REKOVELLE - Menopur mixed protocol algorithm(up to 20 days)
研究者
Dr François Bissonnette
Principal Investigator
Clinique Ovo