A Phase 3, Randomized, Double-blind, Active-controlled, Non-inferiority Trial to Investigate the Efficacy and Safety of a Single Injection of SCH 900962 (Corifollitropin Alfa) to Induce Multifollicular Development for Controlled Ovarian Stimulation (COS) Using Daily Recombinant FSH (recFSH) as a Reference in Women Aged 35 to 42 Years (Phase 3; Protocol No. P06029)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,424
- 主要终点
- Percentage of Participants With a Vital Pregnancy
研究概览
简要总结
The purpose of this study is to show that a single injection of SCH 900962/MK-8962 is non-inferior to daily injections of recombinant follicle-stimulating hormone (recFSH) during the first week of ovarian stimulation in terms of the number of vital pregnancies (ie, presence of at least one fetus with heart activity as assessed by ultrasound at least 35 days after embryo transfer) in women aged 35 to 42 years undergoing controlled ovarian stimulation (COS) prior to in vitro fertilization (IVF) or intracytoplasmic sperm injection (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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 42 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Willing and able to provide written informed consent for trial P06029 as well as for the Frozen-Thawed Embryo Transfer (FTET) follow-up trial P06031, and for the pharmacogenetic analysis (if applicable).
- •Female and >=35 to <=42 years of age with indication for COS and IVF/ICSI.
- •Body weight ≥50.0 kg, body mass index (BMI) >=18.0 to <=32.0 kg/m
- •Regular spontaneous menstrual cycle with variation not outside the 24-35 days.
- •Ejaculatory sperm must be available (donated and/or cryopreserved sperm is allowed).
- •Results of clinical laboratory tests, cervical smear, physical examination within normal limits or clinically acceptable to the investigator.
- •Adhere to trial schedule.
排除标准
- •A recent history of/or any current endocrine abnormality.
- •A history of ovarian hyper-response or ovarian hyperstimulation syndrome (OHSS).
- •A history of/or current polycystic ovary syndrome.
- •More than 20 basal antral follicles <11 mm (both ovaries combined) in the early follicular phase.
- •Less than 2 ovaries or any other ovarian abnormality.
- •Unilateral or bilateral hydrosalpinx.
- •Intrauterine fibroids ≥5 cm or any clinically relevant pathology, which could impair embryo implantation or pregnancy continuation.
- •More than three unsuccessful COS cycles for IVF/ICSI since the last established ongoing pregnancy (if applicable).
- •A history of non- or low ovarian response to FSH/human menopausal gonadotropin (hMG) treatment.
- •A history of recurrent miscarriage.
- •FSH >15.0 IU/L or luteinizing hormone (LH) >12.0 IU/L during the early follicular phase.
- •Positive for human immunodeficiency virus (HIV) or Hepatitis B.
- •Contraindications for the use of gonadotropins or gonadotropin releasing hormone (GnRH) antagonists.
- •A recent history of/or current epilepsy, thrombophilia, diabetes, cardiovascular, gastro-intestinal, hepatic, renal or pulmonary or auto-immune disease requiring regular treatment.
- •Smoking or recently stopped smoking (ie, within the last 3 months prior to signing informed consent).
- •A recent history or presence of alcohol or drug abuse.
- •The participant or the sperm donor has known gene defects, genetic abnormalities, or abnormal karyotyping, relevant for the current indication or for the health of the offspring.
- •Prior or concomitant medications disallowed by protocol.
研究组 & 干预措施
Single injection of 150 µg SCH 900962 (MK-8962)
Participants received a single injection of 150 ug SCH 900962 (MK-8962) on Stimulation Day 1 and 7 injections with placebo-recFSH from Stimulation Days 1-7
干预措施: SCH 900962 / Corifollitropin alfa / Org 36286 (Biological)
Single injection of 150 µg SCH 900962 (MK-8962)
Participants received a single injection of 150 ug SCH 900962 (MK-8962) on Stimulation Day 1 and 7 injections with placebo-recFSH from Stimulation Days 1-7
干预措施: Placebo for recFSH (Drug)
Daily 300 IU recFSH
Participants received a single injection of placebo SCH 900962 (MK-8962) on Stimulation Day 1 and 7 injections of recFSH from Stimulation Days 1-7
干预措施: RecFSH / follitropin beta (Biological)
Daily 300 IU recFSH
Participants received a single injection of placebo SCH 900962 (MK-8962) on Stimulation Day 1 and 7 injections of recFSH from Stimulation Days 1-7
干预措施: Placebo for SCH 900962 (Drug)
结局指标
主要结局
Percentage of Participants With a Vital Pregnancy
时间窗: Vital pregnancy will be assessed by ultrasound at least 35 days after embryo transfer (with a timeframe of 35-42 days). Time from start of study treatment to embryo transfer is maximally 24 days.
Vital pregnancy was defined as the presence of at least 1 fetus with heart activity at least 35 days (≥5 weeks) after embryo transfer in the controlled ovarian stimulation (COS) treatment cycle
次要结局
- Number of Oocytes Retrieved Per Attempt(Maximally 21 days after the start of study treatment.)
- Live Birth Rate(Approximately nine months after embryo transfer)
- Number of Participants With Moderate or Severe Ovarian Hyperstimulation Syndrome (OHSS)(Up to approximately 1 month after oocyte pick-up)
- Number of Participants Who Cancelled the Cycle Due to a (Serious) Adverse Event(Up to time of embryo transfer (maximum of 24 days after start of study drug))