Effectiveness of Generic Cetrorelix Acetate Versus Reference Cetrorelix Acetate for Ovarian Stimulation Using a GnRH Antagonist Protocol in Women Undergoing IVF: A Multicenter Non-inferiority, Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,338
- 试验地点
- 1
- 主要终点
- Cumulative live birth rate
研究概览
简要总结
The goal of this clinical trial is to compare the clinical outcomes using different cetrorelix acetate in the context of a GnRH antagonist protocol for ovarian stimulation in women undergoing IVF or intracytoplasmic sperm injection(ICSI) treatment.The main question it aims to answer is whether the generic cetrorelix acetate is non-inferior to the reference product in the GnRH antagonist based protocol for women undergoing IVF. Ovarian stimulation was achieved by several types of follicle-stimulating hormone(FSH) or by FSH combined with luteinizing hormone activity. Daily dose of generic cetrorelix acetate (0.25 mg SC) or original cetrorelix acetate (0.25 mg SC) will be administered when the lead follicle was 14 mm. When more than two follicles reached 17 mm, oocyte maturation was triggered with 250 mcg of recombinant human chorionic gonadotropin.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 42 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Infertile couples plan to undergo IVF / ICSI pregnancy treatment into screening procedures and clinical study
- •All subjects should sign the informed consent form
- •Infertile women <43 years old
- •With flexible GnRH antagonist
排除标准
- •Subjects could not enter the study if they meet any one of the following criteria
- •Preimplantation Genetic Testing (PGT)
- •Untreated hydrosalpinges, moderate or severe endometriosis, recurrent spontaneous miscarriage, endometrial pathology, uterine malformations, etc
- •Endocrine diseases (such as hyperthyroidism, hyperprolactinemia, etc.) or other systemic disease and other systemic diseases (such as hypertension, diabetes, etc.)．
- •Other factors were considered inappropriate by the investigator to participate, or assisted reproductive technology/pregnancy contraindications
研究组 & 干预措施
Generic cetrorelix acetate
干预措施: Generic cetrorelix acetate (Drug)
Reference cetrorelix acetate
干预措施: Reference cetrorelix acetate (Drug)
结局指标
主要结局
Cumulative live birth rate
时间窗: Through study completion, an average of 18 months
For the first live birth (gestation≥ 24 weeks) in one in vitro fertilization/intracytoplasmic sperm injection egg retrieval cycle (fresh and frozen-thawed embryo transfer cycle)
次要结局
未报告次要终点
研究者
He Cai
Principal Investigator
Northwest Women's and Children's Hospital, Xi'an, Shaanxi