NCT02047227已完成3 期
A Phase III, Randomized, Controlled, Single-blind, Multicentre, Parallel Arm Trial to Assess the Efficacy and Safety of Pergoveris® (Follitropin Alfa and Lutropin Alfa) and GONAL-f® (Follitropin Alfa) for Multifollicular Development as Part of an Assisted Reproductive Technology Treatment Cycle in Poor Ovarian Responders, as Defined by the European Society of Human Reproduction and Embryology Criteria
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
- 939
- 试验地点
- 1
- 主要终点
- Number of Oocytes Retrieved
研究概览
简要总结
This is a Phase 3, randomized, controlled, single-blind, multicenter, parallel-arm trial to assess the safety and efficacy of Pergoveris® (recombinant human follicle stimulating hormone [r-hFSH]/recombinant human luteinising hormone [r-hLH]) and GONAL-f® for multifollicular development as part of an assisted reproductive technology (ART) treatment cycle in poor ovarian responders, as aligned with the 2011 Consensus Meeting of the European Society of Human Reproduction and Embryology (ESHRE) criteria.
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
- 18 Years 至 41 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Poor ovarian responders according to specific criteria that are aligned with poor ovarian response (POR) criteria defined by the 2011 Consensus Meeting of the European Society of Human Reproduction and Embryology (ESHRE) as mentioned in the protocol
- •Female subjects, less than (<) 41 years of age (according to date of birth at time of informed consent) who are eligible for ovarian stimulation and ART treatment, including intracytoplasmic sperm injection (ICSI)
- •Absence of anatomical abnormalities of the reproductive tract that would interfere with implantation or pregnancy
- •Absence of any medical condition in which pregnancy is contraindicated
- •Body mass index 18 to 30 kilogram per square meter (kg/m^2), inclusive
- •Motile, ejaculatory sperm must be available (donated and/or cryopreserved sperm is allowed). Intracytoplasmic sperm injection will be allowed during this trial
- •Minimum of 1 month without treatment with either clomiphene citrate or gonadotrophins prior to screening
- •Signed and dated informed consent indicating that the subject has been informed of all the pertinent aspects of the trial prior to enrollment
排除标准
- •Two episodes of POR after maximal stimulation
- •History or presence of tumors of the hypothalamus or pituitary gland
- •History or presence of ovarian enlargement or cyst of unknown etiology, or presence of an ovarian cyst greater than 25 mm on the day of randomization
- •Presence of endometriosis Grade III - IV, confirmed or suspected
- •Presence of uni- or bilateral hydrosalpinx
- •Abnormal gynecological bleeding of undetermined origin
- •Contraindication to being pregnant and/or carrying a pregnancy to term
- •History or presence of ovarian, uterine or mammary cancer
- •Use of testicular or epididymal sperm
- •Other protocol defined exclusion criteria could apply
研究组 & 干预措施
Pergoveris®
Experimental
干预措施: Pergoveris® (Drug)
Pergoveris®
Experimental
干预措施: Recombinant human chorionic gonadotrophin (r-hCG) (Drug)
GONAL-f®
Active Comparator
干预措施: GONAL-f® (Drug)
GONAL-f®
Active Comparator
干预措施: Recombinant human chorionic gonadotrophin (r-hCG) (Drug)
结局指标
主要结局
Number of Oocytes Retrieved
时间窗: At approximately 34 to 38 hours after r-hCG administration (Day 113)
Mean number of oocytes retrieved on the day of ovum pick up (OPU) was calculated. Oocyte retrieval was a technique used in in-vitro fertilization in order to remove oocytes from the ovary of the female, enabling fertilization outside the body.
次要结局
- Ongoing Pregnancy Rate(70 days after embryo transfer (Day 185))
- Live Birth Rate(Approximately 180 days following ongoing pregnancy determination (Day 365))
- Embryo Implantation Rate(35-42 days post r-hCG administration (Day 154))
- Clinical Pregnancy Rate(35-42 days post r-hCG administration (Day 154))
- Biochemical Pregnancy Rate(15 to 20 days post r-hCG administration (Day 132))
研究者
研究点 (1)
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