A Randomized, Double Blind, Multi-Center, Placebo Controlled Study To Evaluate The Efficacy, Safety, And Tolerability Of Multiple Doses Of NT100 Following IVF In Women With A History Of Repeated IVF Failures (Thrive-IVF)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 157
- 试验地点
- 19
- 主要终点
- Ongoing clinical pregnancy rate
研究概览
简要总结
The purpose of this study is to evaluate the efficacy, safety and tolerability of multiple doses of subcutaneous NT100 vs placebo following in vitro fertilization (IVF) in women with a history of repeated IVF failures.
详细描述
NT-03 will be a randomized, double blind, multi-center, placebo controlled study of multiple doses of subcutaneous NT100 following IVF in women with a history of repeated IVF failures. Approximately 150 subjects will be randomized in a 1:1:1 ratio to receive subcutaneous NT100 low dose, NT100 high dose, or placebo, qd for up to 4 weeks.
Screening will include a standard IVF stimulation protocol, followed by fertilization and culture of embryos. If the subject remains eligible, she will be randomized to receive study drug. All subjects will be followed for 4 weeks after the last dose of study drug. At Week 10 of gestation, subjects who are pregnant will roll over into a follow-up study (NT-04) to assess subsequent pregnancy, delivery, and neonatal outcomes.
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
- 21 Years 至 38 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pre-menopausal female 21-38 years of age at screening
- •History of repeated IVF failures despite transfer of good-quality embryos, defined as follows:
- •...1) 3 or more IVF cycles involving transfer of at least two good-quality cleavage-stage embryos or at least one good-quality blastocyst (2010 SART (Society for Assisted Reproductive Technologies) grading criteria)that resulted in one of the following outcomes:
- •* .....a) no pregnancy
- •* .....b) biochemical pregnancy
- •* .....c) spontaneous abortion of an intrauterine clinical pregnancy before or equal to completed Week 8 of gestation
- •...2) At least two of the eligible IVF failures must have involved transfer of fresh embryos
- •...3) At least two of the eligible IVF failures must have involved retrieval of at least 5 oocytes
- •...4) No live birth, abortion later than Week 8 of gestation, or stillbirth may have occurred since the first of these IVF failures
- •Body mass index (BMI) of 19-38 kg per m2 at screening
- •TSH (thyroid-stimulating hormone) less than or equal to 4.0 mIU/L(milli-International units per Liter) for subjects with no history of hypothyroidism, or TSH less than or equal to 2.5 mIU/L for subjects with a history of hypothyroidism, at screening
排除标准
- •Prior diagnosis of moderate or severe ovarian hyperstimulation syndrome (OHSS)
- •Clinically confirmed polycystic ovary syndrome (PCOS)
- •History of a major congenital anomaly in the subject, her current male partner, or first degree relative of either the subject or her current male partner
- •Known karyotype abnormalities in either the subject or her current male partner / sperm donor
- •Any prior pregnancy terminated for a fetal medical condition
- •History of severe (stage IV) endometriosis
- •Current or past systemic autoimmune disease
- •Any uncontrolled clinically significant medical condition (e.g. asthma, Type II diabetes, infection)
研究组 & 干预措施
NT100 Dose 1
NT100 Dose 1
干预措施: NT100 (Drug)
NT100 Dose 2
NT100 Dose 2
干预措施: NT100 (Drug)
Placebo
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Ongoing clinical pregnancy rate
时间窗: Week 8 of gestation
The primary efficacy outcome measure is the ongoing clinical pregnancy rate at Week 8 of gestation.
次要结局
- Number of subjects with adverse events and serious adverse events(through 4 weeks after last dose of study drug (up to Week 10 of gestation))
- Changes in clinical laboratory parameters following study drug exposure(through 4 weeks after the last dose of study drug (up to Week 10 of gestation))
- Moderate to severe ovarian hyperstimulation syndrome (OHSS) rate(through Week 10 of gestation)
- Biochemical evidence of pregnancy rate (as measured by hCG)(Week 4 of gestation)
- Ongoing clinical pregnancy rate(Weeks 6 and 10 of gestation)
- Implantation rate following embryo transfer(Week 8 of gestation)