NCT05263388已完成3 期
A Randomised, Controlled, Assessor-blind, Parallel Groups, Multicentre, Multinational Trial Comparing the Ovarian Response of a Starting Dose of 15 μg Follitropin Delta (REKOVELLE) to a Starting Dose of 225 IU Follitropin Alfa (GONAL-F) in Conventional Regimens in Controlled Ovarian Stimulation in Women Undergoing an Assisted Reproductive Technology Programme
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 302
- 试验地点
- 1
- 主要终点
- Number of Oocytes Retrieved
研究概览
简要总结
Hormone preparations like REKOVELLE and GONAL-F are used to make the body produce multiple egg sacs, allowing more eggs to be collected from women undergoing infertility treatment.
The main purpose of this trial is to see how many eggs are produced with a starting dose of 15 µg REKOVELLE compared to a starting dose of 225 IU GONAL-F. This research is intended to provide more knowledge about REKOVELLE, including the doses given in the trial.
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
- Single (Outcomes Assessor)
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
- •Infertile women aged 18-40 years
- •Diagnosed with tubal infertility, unexplained infertility, mild endometriosis (stage I/II) or partners with decreased sperm quality
- •Medically eligible for in vitro fertilization (IVF) and/or intracytoplasmic sperm injection (ICSI)
- •Infertility for at least one year for participants ≤ 37 years or for at least 6 months for participants ≥ 38 years
- •Regular menstrual cycles of 21-35 days.
排除标准
- •Known condition of not functioning ovaries
- •Known advanced endometriosis (stage III/IV)
- •Considered unsuitable for controlled ovarian stimulation with a dosing regimen corresponding to approximately 225 IU/day gonadotropin, as judged by the investigator
- •History of previous episode of OHSS or exuberant ovarian response to gonadotropins, and polycystic ovarian syndrome
- •Any known hormonal or metabolic abnormalities which can compromise participation in the trial
- •Known tumors of the ovary, breast, uterus, adrenal gland, pituitary or hypothalamus
研究组 & 干预措施
REKOVELLE (Follitropin Delta)
Experimental
干预措施: REKOVELLE (Follitropin Delta) (Drug)
GONAL-F (Follitropin Alfa)
Active Comparator
干预措施: GONAL-F (Follitropin Alfa) (Other)
结局指标
主要结局
Number of Oocytes Retrieved
时间窗: On day of oocyte retrieval (Up to 22 days after start of stimulation)
The number of oocytes retrieved was recorded at the oocyte retrieval visit.
次要结局
- Number of Follicles (Total) at End-of-stimulation(At end-of-stimulation (up to 20 stimulation days))
- Size of the Follicles at End-of-stimulation(At end-of-stimulation (up to 20 stimulation days))
- Serum Concentrations of Estradiol at End-of-stimulation(At end-of-stimulation (up to 20 stimulation days))
- Serum Concentrations of Progesterone at End-of-stimulation(At end-of-stimulation (up to 20 stimulation days))
- Number of Fertilized Oocytes(On day 1 after oocyte retrieval (up to 23 days after start of stimulation))
- Fertilization Rate(On day 1 after oocyte retrieval (up to 23 days after start of stimulation))
- Number of Blastocysts and Number of Good Quality Blastocysts(On Day 5 or Day 6 (as applicable) after oocyte retrieval (up to 27 or 28 days after start of stimulation))
- Total Gonadotropin Dose(Up to 20 stimulation days)
- Number of Stimulation Days(Up to 20 stimulation days)
- Proportion of Subjects With Early Ovarian Hyperstimulation Syndrome (OHSS) (Overall and by Grade) and/or Preventive Interventions for Early OHSS(Up to 9 days after triggering of final follicular maturation)
研究者
研究点 (1)
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