NCT03088137已完成3 期
Multicentre Study to Compare Efficacy and Safety of Primapur and Gonal-f in Women 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
- 发起方
- IVFarma LLC
- 入组人数
- 118
- 试验地点
- 3
- 主要终点
- Oocytes (Intention-to-Treat, ITT)
研究概览
简要总结
The purpose of this study is to show equivalence with regard to the number of oocytes retrieved between follitropin alfa (pen-injectors) Primapur® and Gonal-f® in woman undergoing IVF/ICSI
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
- 20 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Infertility due to tubal factor and/or male factor
- •Age between 20 and 35 years with regular menstrual cycles of 21-35 days
- •First or second cycle in the present series of ART
- •BMI (body mass index) ≥ 18 ≤ 30 kg/m2
- •Basal FSH (follicle stimulating hormone) < 10 IU/L (cycle day 2-5)
- •E2 (estradiol) levels < 50pg/mL (cycle day 2)
- •AMH (anti-mullerian hormone) ≥ 1.0 ng/ml
- •Antral follicle ≥ 4 to ≤ 15 follicles (both ovaries)
- •Presence of both ovaries and normal uterine cavity
- •Informed consent
排除标准
- •Presence of pregnancy
- •Hypersensitivity to follitropin alfa
- •Ovarian cysts
- •History of ≥2 succeeding ART (assisted reproductive technology) cycles IVF (in vitro fertilization) and/or ICSI (Intracytoplasmic sperm injection) before the study cycle
- •Previous history of severe ovarian hyperstimulation syndrome
- •Presence of polycystic ovaries (PCO)
- •Presence of endometriosis and hydrosalpinx
- •Presence of uterine disorders
- •History of poor (< 4 oocytes) or hyper (> 25 oocytes) responses to FSH treatment at dose 150 IU and GnRH-antagonist (gonadotropin-releasing hormone) protocol
- •Premature ovarian failure
- •Ectopic pregnancy (3 month before the study cycle)
- •Presence of clinically significant systemic disease
- •Presence of chronic cardiovascular, hepatic, renal or pulmonary disease
- •Presence of endocrine disorder
- •Neoplasia
- •Male infertility without mobile spermatozoa in the ejaculate, that need MESA (Microsurgical epididymal sperm aspiration)/TESE (testicular sperm extraction)/TESA (testicular sperm aspiration)
- •Smoking > 10 cigarettes/day
- •Narcomania, alcoholism
- •Planned PGS (preimplantation genetic screeneing) /PGD (preimplantation genetic diagnosis)
研究组 & 干预措施
Primapur (Follitropin alfa)
Experimental
干预措施: Follitropin alfa (Primapur) (Drug)
Gonal-f (Follitropin alfa)
Active Comparator
干预措施: Follitropin alfa (Gonal-f) (Drug)
结局指标
主要结局
Oocytes (Intention-to-Treat, ITT)
时间窗: From date of randomization up to 18 days
The total number of retrieved oocytes at the day of ovum pick-up. No more than 37 hours from the introduction of the trigger of ovulation (hCG or GnRH-agonist). The equivalence in the number of retrieved oocytes was tested using a predetermined equivalence margin of +/- 3.4 oocytes.
次要结局
- Percentage of Patients With the Evidence for Clinical Pregnancy(The 10th week after embryo transfer)
- Number of Follicles With Size ≥ 16 mm(From date of randomization up to 16 days)
- Mature Oocytes(From date of randomization up to 18 days)
- Fertilised Oocytes(From date of randomization up to 19 days)
- Percentage of Patients With Embryo Transfer(From date of randomization up to 25 days)
- Total Dose of Follitropin Alfa(From date of randomization up to 16 days)
- Number of Days of Follitropin Alfa Treatment(From date of randomization up to 16 days)
- Number of Patients With Follitropin Alfa Dose Correction(From date of randomization up to 16 days)
- Number of Patients With Cycle Cancellation(From date of randomization up to 16 days)
- Number of No-responders(From date of randomization up to 8 days)
- Percentage of Patients With Serum hCG More Than 25 IU/l(From date of randomization up to 42 days)
研究者
研究点 (3)
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