The Endocrine Efficacy of Either Recombinant Luteinizing Hormone (r-LH) or Low Dose Recombinant Human Chorionic Gonadotropin (r-hCG) Supplementation for Recombinant Follicle Stimulating Hormone (r-FSH) Stimulation in Normogonadotrophic Women Undergoing in Vitro Fertilization (IVF)/Intracytoplasmic Sperm Injection (ICSI) Therapy Following a Long-term Gonadotropin Releasing Hormone (GnRH) Agonist Down Regulation Protocol
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The Oestradiol Concentration on the Day of Ovulation Induction
研究概览
简要总结
The study is a prospective, randomised, controlled, and non-blinded multi-center pilot study to evaluate endocrine efficacy of recombinant luteinizing hormone versus recombinant human chorionic gonadotropin administered during controlled ovarian stimulation for IVF/ICSI in normogonadotrophic women.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women who plan to undergo IVF or ICSI treatment
- •Woman's age > 18 years but ≤ 35 years
- •Regular menstrual cycle (25-34 days)
- •BMI 18 to 30 inclusive
- •Signed patient information and informed consent forms
排除标准
- •More than 2 prior IVF/ICSI attempts
- •Diabetes mellitus, epilepsy, lever-, kidney-, heart- and metabolism disorders, according to the Investigator's assessment.
研究组 & 干预措施
recombinant luteinizing hormone
150 IU r-LH, recombinant luteinising hormone, from treatment day 1 (stimulation day 1) until day of r-hCG administration (normally treatment day 10 to 14)
干预措施: recombinant luteinizing hormone (r-LH) (Drug)
recombinant human chorionic gonadotrofin
25 IU of r-hCG from treatment day 1 (stimulation day 1) until day of r-hCG administration (normally treatment day 10 to 14 )
干预措施: recombinant human chorionic gonadotropin (r-hCG) (Drug)
结局指标
主要结局
The Oestradiol Concentration on the Day of Ovulation Induction
时间窗: treatment day 10 to 14
次要结局
未报告次要终点
研究者
Peter Humaidan
Prof. M.D. D.M.Sc.
Regionshospitalet Viborg, Skive