A Parallel-group Treatment, 2-arm Study to Compare the Efficacy and Safety of Follitropin Alfa and Lutropin Alfa Fixed Dose Combination Versus hMG for Inducing Follicular Development in Japanese Participants With LH and FSH Deficiency Undergoing ART
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 266
- 试验地点
- 21
- 主要终点
- Total number of oocytes retrieved
研究概览
简要总结
The purpose of this study is to assess the efficacy and safety of follitropin alfa/lutropin alfa in Japanese participants with Luteinizing hormone (LH) and Follicle stimulating hormone (FSH) deficiency undergoing Assisted reproductive technology (ART).
The study duration is approximately 5.5 months for nonpregnant participants and 13 months for participants with confirmed pregnancy in Part A.
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 42 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Participants who are premenopausal wishing to conceive
- •Participants with maximum 1 previous stimulation for assisted reproductive technology (ART) without pregnancy
- •Japanese Participants
- •Participants are women with Luteinizing hormone (LH) and Follicle stimulating hormone (FSH) deficiency congenital or acquired
- •Participants have a vaginal ultrasound scan showing both ovaries and no clinically significant uterine abnormality and a normal antral follicle count (AFC) of at least 5 follicles 2 to 10 millimeter (mm) in diameter per ovary
- •A semen analysis of the male partner been performed within 3 months prior to signature of informed consent and suitable for assisted reproductive technology
- •Participants have a normal cervical ThinPrep® cytologic test, (TCT) or Pap smear within 12 months of Screening. If not available, a cervical smear will be performed as part of screening
- •Other protocol defined criteria may apply
排除标准
- •Participants with history of severe OHSS in any previous ovarian stimulation cycle
- •Participants with Polycystic ovarian syndrome (PCOS) according to Rotterdam modified definition
- •Participants with contraindication to treatment with gonadotropins, hypersensitivity to gonadotropins or to any of the excipients
- •Participants with presence of known or suspected gonadotropin- or estrogen dependent malignancy (example. ovarian-, uterine-, or mammary carcinoma)
- •Participants with ovarian enlargement or cyst of unknown etiology, or presence of an ovarian cyst greater than 25 millimeters before Day 1
- •other protocol defined exclusion criteria may apply
研究组 & 干预措施
Arm 2: Human Menopausal Gonadotropin (hMG)
干预措施: Cetrorelix acetate (Drug)
Arm 2: Human Menopausal Gonadotropin (hMG)
干预措施: Coriogonadotropin alfa (Drug)
Arm 1: Follitropin alfa/lutropin alfa
Participants will receive fixed combination product of recombinant Follitropin alfa (rechFSH)/lutropin alfa (rechLH) in a 2:1 ratio.
干预措施: Cetrorelix acetate (Drug)
Arm 2: Human Menopausal Gonadotropin (hMG)
干预措施: hMG (Drug)
Arm 1: Follitropin alfa/lutropin alfa
Participants will receive fixed combination product of recombinant Follitropin alfa (rechFSH)/lutropin alfa (rechLH) in a 2:1 ratio.
干预措施: Coriogonadotropin alfa (Drug)
Arm 1: Follitropin alfa/lutropin alfa
Participants will receive fixed combination product of recombinant Follitropin alfa (rechFSH)/lutropin alfa (rechLH) in a 2:1 ratio.
干预措施: Follitropin alfa/lutropin alfa (MBJ-0011) (Combination Product)
Arm 1: Follitropin alfa/lutropin alfa
Participants will receive fixed combination product of recombinant Follitropin alfa (rechFSH)/lutropin alfa (rechLH) in a 2:1 ratio.
干预措施: Progesterone gel (Drug)
Arm 2: Human Menopausal Gonadotropin (hMG)
干预措施: Progesterone gel (Drug)
结局指标
主要结局
Total number of oocytes retrieved
时间窗: At approximately 36 to 38 hours after r-hCG administration (Day 4)
Mean number of oocytes retrieved will be 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
- Total dose of gonadotropin (IU) used(At Visit 3 after ovarian stimulation from Day 5 until Day of r-hCG (maximum 18 days))
- Number of Days of Gonadotropin Treatment(At Visit 3 after ovarian stimulation from Day 5-18)
- Total Number of Follicles Measuring greater than or equal to 14 millimeter (mm) and greater than or equal to 17 mm in diameter(During Ovarian stimulation (Day 5 to Day 18))
- Serum Estradiol (E2) levels(At Visit 3 after ovarian stimulation from Day 5-18)
- Proportion of 2 Pronuclei Embryos/Fertilized Oocytes(At 18 (Plus or minus two hours) hours after insemination)
- Number of blastocysts frozen(5 days after insemination)
- Number of Participants With Clinical Pregnancy(35-42 days after Visit 5 (Blastocyst transfer))
- Number of Participants With Ongoing Pregnancy(up to 80 days after blastocyst transfer (pregnancy week 11 to 12))
- Number of Participants With Treatment-Emergent Adverse Events and Treatment related Adverse Events(5.5 months for nonpregnant participants and 13 months for participants with confirmed pregnancy)
- Number of Participants With Ovarian Hyperstimulation Syndrome (OHSS)(5.5 months for nonpregnant participants and 13 months for participants with confirmed pregnancy)
- Number of Participants With Mild, Moderate, and Severe Ovarian Hyperstimulation Syndrome(5.5 months for nonpregnant participants and 13 months for participants with confirmed pregnancy)
- Number of Cycles Cancelled due to Risk of Ovarian Hyperstimulation Syndrome(5.5 months for nonpregnant participants and 13 months for participants with confirmed pregnancy)
- Number of Participants With Clinically Significant Changes in Laboratory Parameters and Vital Signs(5.5 months for nonpregnant participants and 13 months for participants with confirmed pregnancy)
- Number of Participants Experiencing Local Reactions(5.5 months for nonpregnant participants and 13 months for participants with confirmed pregnancy)