NCT05149924已完成3 期
A Multicenter, Randomized, Single-blind, Active-controlled, Phase III Clinical Study to Compare the Efficacy and Safety of QL1012(Recombinant Human Follicle-stimulating Hormone) and Gonal-f ® in Women Undergoing Controlled Ovarian Hyperstimulation for Assisted Reproductive Treatment
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
- 354
- 试验地点
- 1
- 主要终点
- Number of oocytes retrieved
研究概览
简要总结
The study is conducted to confirm equivalence between QL1012 (a new biosimilar formulation of Recombinant Human Follicle-stimulating Hormone) and Gonal-f® with respect to the number of oocytes retrieved in women for assisted reproductive treatment.
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 (Investigator)
入排标准
- 年龄范围
- 20 Years 至 39 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent
- •Aged 20 ~ 39 years(inclusive)
- •Body mass index (BMI) between 18~30 kg/m2(inclusive)
- •Regular menstrual cycle (25~35 days)
- •Basal FSH < 10 IU/L (menstrual cycle day 2~5)
排除标准
- •History of ≥3 previously completed IVF/ICSI-ET cycles without clinical pregnancy
- •History of ≥3 recurrent spontaneous miscarriages
- •Patients with high risk of ovarian hyperstimulation syndrome (OHSS)
- •Primary ovarian failure or poor responders to ovarian stimulation
- •Presence of pregnancy in previous 3 months
- •Presence of clinically significant systemic disease, endocrine disease or metabolic abnormalities
- •History of malignant tumors of the ovary, breast, uterus, hypothalamus, pituitary gland, etc.;
研究组 & 干预措施
QL1012，Recombinant Human Follicle Stimulating Hormone for Injection
Experimental
干预措施: QL1012 (Drug)
Gonal-f ®
Active Comparator
干预措施: Gonal-f ® (Drug)
结局指标
主要结局
Number of oocytes retrieved
时间窗: 36-38 hours after hCG administration
36-38 hours after hCG administration, transvaginal ultrasound-guided aspiration was performed as required, and the number of oocytes was recorded.
次要结局
- Serum estradiol concentration(From date of randomization up to 16 days)
- Fertilization Rate of Oocytes(Day 1 of IVF/ICSI)
- Rate of high-quality embryos(3 days after oocyte retrieval)
- clinical pregnancy rate(35 ± 4 days after embryo transfer)
- Endometrial thickness(From date of randomization up to 16 days)
- Ongoing pregnancy rate(Ten weeks after embryo transfer)
- Total dose of r-hFSH administered(From date of randomization up to 16 days)
- Number of days of r-hFSH stimulation(From date of randomization up to 16 days)
- Implantation rate(five to six weeks after oocyte retrieval)
研究者
研究点 (1)
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