NCT03506243已完成3 期
A Phase III, Multicenter, Blinded, Randomized, Controlled, Parallel, Comparative Study for the Evaluation of Safety and Efficacy of rhFSH Injection Compared With Gonal-F® Pen Undergoing Controlled Ovarian Hyper Stimulation IVF-ET
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 451
- 试验地点
- 1
- 主要终点
- The total number of oocytes retrieved
研究概览
简要总结
This study is for evaluating safety and efficacy of Recombinant human follicle-stimulating hormone (Follitrope) injection compared with Gonal-F® Pen undergoing controlled ovarian hyper stimulation in vitro fertilization - embryo transfer (IVF-ET) in China
详细描述
This is a Phase 3, multicenter, blinded, randomized, controlled, parallel, comparative study for the evaluation of safety and efficacy of Recombinant human follicle-stimulating hormone injection (Follitrope) compared with Gonal-F® Pen undergoing controlled ovarian hyper stimulation in vitro fertilization - embryo transfer (IVF-ET) in China.
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
- Double (Investigator, Outcomes Assessor)
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
- •Infertile adult women between 20 and 39 years at screening.
- •Infertile adult women with regular menstrual cycles of 25 to 35 days at screening.
- •Normal basal serum FSH, LH, E2, and P levels at the early follicular phase at screening.
- •If the cause of infertility is due to following reasons:
- •Tubal factor
- •Unknown reason
- •Male infertility
- •Combined factors
- •Willing to give voluntary written informed consent.
排除标准
- •Patients with a clinically significant systemic disease, endocrine or metabolic abnormalities.
- •Body Mass Index > 30 (BMI; kg/m2) at screening.
- •Patients with a uterine (fibroids (diameter greater than or equal to 2CM endometrium), endometrial polyps, intrauterine adhesions, uterine malformations), ovaries (polycystic ovary, ovarian cysts) or adnexa (hydrosalpinx) abnormalities at screening.
- •patients with uterine, ovarian surgery treatment
- •Patients who experienced of severe ovarian hyperstimulation symptoms (OHSS) in previous IVF cycles.
- •Patients who have shown poor response with gonadotropin hormone therapy.
- •*At least two of the following three features must be present:
- •① A previous POR(≤3 retrieved oocyte with a conventional stimulation protocol)
- •② An abnormal ovarian reserve test (i.e. AFC < 5 follicles) at screening.
- •Abnormal metrorrhagia due to unknown reason at screening.
- •At least one of husband and wife to accept donor sperm or donor eggs or PGD subject
- •Subjects who are positive for HIV or syphilis at screening.
- •Significant known psychiatric disorder or who unable to understand the objectives and methods, etc. of this clinical trial and unable to comply with the study procedures at screening.
- •Presence of elicit alcohol, smoke or drug abuse habit at screening.
- •History of hypersensitivity to rhFSH or other pharmaceutical excipients of this drug.
- •Participation in any other clinical trial after registering for this study or have participated in another clinical study within 3 month before randomization in this study.
- •History of tumors of the ovary, breast, uterus, hypothalamus or pituary gland.
- •More than 3 times previously consecutive unsuccessful in vitro fertilization cycles at screening.
- •Subjects with no clomiphene citrate or gonadotropin treatment within 1 month before randomization.
- •Positive serum pregnancy test at screening.
- •14 ± 2 days after the demotion, results of subjects who does not belong to the standard (antral follicle size ≥10mm)
研究组 & 干预措施
Test group
Experimental
Follitrope PFS
干预措施: Follitrope PFS (Biological)
Control group
Active Comparator
Gonal-F pen
干预措施: Gonal-f pen (Biological)
结局指标
主要结局
The total number of oocytes retrieved
时间窗: 15 days after using FSH
The total number of oocytes retrieved
次要结局
- Total dose and duration of FSH administration(Throughout the study completion (e.g., 10 days))
- Clinical pregnancy rate(5 weeks after the embryo transfer)
- No. of follicles with diameter equal or more than 14 mm on hGH injection day(The day of hGH injection)
- On-going pregnancy rate(10 weeks after the embryo transfer)
- No. of embryo transferred(3 days after the ovum pick-up)
研究者
研究点 (1)
Loading locations...
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