A Multi-Center, Randomized, Open-Label Evaluation of MENOPUR® Versus FOLLISTIM® in GnRH Antagonist Cycles
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 173
- 试验地点
- 7
- 主要终点
- Percentage of Participants With Ongoing Pregnancy at Week 8
研究概览
简要总结
To compare the efficacy and safety of highly purified menotropin (Menopur®) with that of follitropin beta (FOLLISTIM®) in patients who are undergoing gonadotropin-releasing hormone (GnRH) antagonist in vitro fertilization (IVF) cycles
详细描述
This multicenter, randomized, open-label exploratory study will be performed in approximately 200 healthy females undergoing in vitro fertilization (IVF). Each study center will follow its study center standard practice for in vitro fertilization (IVF) within the study parameters as noted in this protocol. The study centers will use marketed products purchased from Schraft's Pharmacy for all phases of the study (down-regulation, stimulation, ovulation induction, and luteal support). Subjects will be randomly assigned prior to the start of stimulation to highly purified menotropin (Menopur®) or follitropin beta (Follistim Pen®) for stimulation and progesterone vaginal insert (Endometrin®) or progesterone in oil for luteal support. Subjects will return to the study center for regular scheduled clinic visits as required per in vitro fertilization (IVF) protocol at the site and at specified time periods during the cycle for estradiol (E2), progesterone (P4) and human chorionic gonadotropin (hCG) tests, and first serum pregnancy test. All subjects will be required to complete a final study visit at completion of luteal support or negative serum pregnancy test following embryo transfer.
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
- None
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
- •Pre-menopausal females between the ages of 18 and 42 years
- •Body mass index (BMI) of 18-34
- •Early follicular phase (day 2-4) Follicle stimulating hormone (FSH) <15 IU/L and Estradiol (E2) within normal limits
- •Documented history of infertility (e.g., unable to conceive for at least one year, or for 6 months for women >38 years of age, or bilateral tubal occlusion or absence, or male factor but excluding severe male factor requiring invasive or surgical sperm retrieval. Donor sperm may be used.)
- •Transvaginal ultrasound at screening consistent with findings adequate for assisted reproductive technology (ART) with respect to uterus and adnexa
- •Signed informed consent
排除标准
- •Gestational or surrogate carrier, donor oocyte
- •Presence of any clinically relevant systemic disease (e.g., insulin-dependent diabetes mellitus, uterine cancer)
- •Surgical or medical condition which, in the judgment of the Investigator or Sponsor, may interfere with absorption, distribution, metabolism, or excretion of the drugs to be used
- •Previous In vitro fertilization (IVF) or Assisted reproductive technology (ART) failure due to a poor response to gonadotropins. Poor response is defined as development of 2 mature follicles or history of >2 previous failed in vitro fertilization (IVF) cycles.
- •History of recurrent pregnancy loss (>2).
- •Presence of abnormal uterine bleeding of undetermined origin
- •Current or recent substance abuse, including alcohol or smoking >10 cigarettes per day
- •Refusal or inability to comply with the requirements of the Protocol for any reason, including scheduled clinic visits and laboratory tests
- •Participation in any experimental drug study within 30 days prior to Screening
- •Severe male factor requiring invasive or surgical sperm retrieval (e.g., microsurgical epididymal sperm aspiration [MESA], testicular sperm extraction [TESE])
研究组 & 干预措施
Menopur/Endometrin
Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progestrone vaginal insert (Endometrin®) starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained.
干预措施: Menotropin (Drug)
Menopur/Endometrin
Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progestrone vaginal insert (Endometrin®) starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained.
干预措施: Progestrone vaginal insert (Drug)
Menopur/Endometrin
Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progestrone vaginal insert (Endometrin®) starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained.
干预措施: Ganirelix (Drug)
Menopur/Progesterone in Oil
Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone in Oil injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained.
干预措施: Menotropin (Drug)
Menopur/Progesterone in Oil
Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone in Oil injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained.
干预措施: Progesterone in oil (Drug)
Menopur/Progesterone in Oil
Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone in Oil injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained.
干预措施: Ganirelix (Drug)
Follistim/Endometrin
Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progestrone vaginal insert (Endometrin®) starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained.
干预措施: Progestrone vaginal insert (Drug)
Follistim/Endometrin
Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progestrone vaginal insert (Endometrin®) starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained.
干预措施: follitropin beta (Drug)
Follistim/Endometrin
Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progestrone vaginal insert (Endometrin®) starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained.
干预措施: Ganirelix (Drug)
Follistim/Progesterone in Oil
Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone in Oil injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained.
干预措施: follitropin beta (Drug)
Follistim/Progesterone in Oil
Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone in Oil injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained.
干预措施: Progesterone in oil (Drug)
Follistim/Progesterone in Oil
Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone in Oil injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained.
干预措施: Ganirelix (Drug)
结局指标
主要结局
Percentage of Participants With Ongoing Pregnancy at Week 8
时间窗: Week 8 (Week 6 of gestation)
The ongoing pregnancy was defined as a positive fetal heart movement (motion) at approximately six weeks of gestation and confirmed in a follow-up pregnancy ultrasound.
次要结局
- Number of Follicles Observed at Day 15(Day 15)
- Number of Oocytes Retrieved at Day 18(Approximately Day 18)
- Proportion of Oocytes Fertilized of the Total Number of Oocytes Retrieved(Approximately Day 19)
- Number of Embryos Transferred at Three Stages of Development(Approximately Day 24)
- Number of Embryos Frozen at Day 24(Approximately Day 24)
- Participants With Cycle Cancellation Following One In Vitro Fertilization (IVF) Treatment Cycle(Day 1 to Day 24)
- Participants With Biochemical Pregnancy at Day 38(approximately day 38 (Day 14 post embryo transfer))
- Participants With Clinical Pregnancy at Week 7(approximately week 7)
- Participants With Adverse Events (AEs), Including Ovarian Hyperstimulation Syndrome (OHSS)(Day 1 - week 12)
- Number of Live Births(Approximately 10 months)