Lutropin Alfa (Luveris®) in Women at Risk of Poor Response Suppressed With Cetrorelix: an Exploratory Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Number of Oocytes Retrieved
研究概览
简要总结
Evaluate the effectiveness of adding lutropin alfa (recombinant human luteinizing hormone [r-hLH]) in the middle of the follicular phase compared to no addition, in infertile women at risk of poor response stimulated with follitropin alfa (recombinant Follicle-Stimulating Hormone [r-FSH]) under Gonadotropin Releasing Hormone (GnRH) antagonist in vitro fertilization (IVF)/intracytoplasmic sperm injection (ICSI), in the number and quality of oocytes, follicular development, fertilization oocyte, embryo quality, and pregnancy rate.
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
- — 至 38 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Participants who were at risk of poor response by at least one of the following criteria: a) <3 follicles in last cycle, or less than or equal to (</=) 2 metaphase II oocytes, or estradiol (E2) <600 pg/mL; b) Cancellation of previous cycle; c) Early follicular serum Follicle-Stimulating Hormone (FSH) >8.5 milli IU/L
- •Participants with normal baseline luteinizing hormone and E2 levels
- •Regular menstrual cycles of 25-35 days
- •Presence of both ovaries and uterus able to withstand pregnancy
排除标准
- •Participants who had any clinically significant disease including known human immunodeficiency virus (HIV), hepatitis-B virus (HBV)/hepatitis-C virus (HCV) positivity
- •Participants with more than 3 previous assisted reproductive techniques (ART) cycles
- •Participants with polycystic ovaries or cyst of unknown etiology; unexplained gynecological bleeding
- •Participants who had any contraindication to being pregnant
- •Active substance abuse
- •Participants who had simultaneously participated in another clinical drug trial
研究组 & 干预措施
r-FSH + r-hLH
Lutropin alfa (r-hLH) will be administered at a daily dose of 150 International Units (IU) from the presence of at least one follicle greater than (>) 14 millimeter (mm) to complete ovarian stimulation. Follitropin alfa (r-FSH) will be administered at an initial dose of 225-450 IU per day (according to standard center practice); the dose will then be adjusted to ovarian response as assessed by ovarian ultrasound and/or serum estradiol. Participants will also receive analogous GnRH antagonist and natural progesterone, as per standard center practice. To complete follicular maturation and trigger ovulation, a single dose of 250 milligrams (mg) of recombinant Human Chorionic Gonadotropin (r-hCG) will be administered subcutaneously at 12 hours after the last injection of lutropin alfa and/or follitropin alfa and analogous GnRH antagonist.
干预措施: r-FSH (Drug)
r-FSH + r-hLH
Lutropin alfa (r-hLH) will be administered at a daily dose of 150 International Units (IU) from the presence of at least one follicle greater than (>) 14 millimeter (mm) to complete ovarian stimulation. Follitropin alfa (r-FSH) will be administered at an initial dose of 225-450 IU per day (according to standard center practice); the dose will then be adjusted to ovarian response as assessed by ovarian ultrasound and/or serum estradiol. Participants will also receive analogous GnRH antagonist and natural progesterone, as per standard center practice. To complete follicular maturation and trigger ovulation, a single dose of 250 milligrams (mg) of recombinant Human Chorionic Gonadotropin (r-hCG) will be administered subcutaneously at 12 hours after the last injection of lutropin alfa and/or follitropin alfa and analogous GnRH antagonist.
干预措施: r-hLH (Drug)
r-FSH + r-hLH
Lutropin alfa (r-hLH) will be administered at a daily dose of 150 International Units (IU) from the presence of at least one follicle greater than (>) 14 millimeter (mm) to complete ovarian stimulation. Follitropin alfa (r-FSH) will be administered at an initial dose of 225-450 IU per day (according to standard center practice); the dose will then be adjusted to ovarian response as assessed by ovarian ultrasound and/or serum estradiol. Participants will also receive analogous GnRH antagonist and natural progesterone, as per standard center practice. To complete follicular maturation and trigger ovulation, a single dose of 250 milligrams (mg) of recombinant Human Chorionic Gonadotropin (r-hCG) will be administered subcutaneously at 12 hours after the last injection of lutropin alfa and/or follitropin alfa and analogous GnRH antagonist.
干预措施: Analogous GnRH antagonist (Drug)
r-FSH + r-hLH
Lutropin alfa (r-hLH) will be administered at a daily dose of 150 International Units (IU) from the presence of at least one follicle greater than (>) 14 millimeter (mm) to complete ovarian stimulation. Follitropin alfa (r-FSH) will be administered at an initial dose of 225-450 IU per day (according to standard center practice); the dose will then be adjusted to ovarian response as assessed by ovarian ultrasound and/or serum estradiol. Participants will also receive analogous GnRH antagonist and natural progesterone, as per standard center practice. To complete follicular maturation and trigger ovulation, a single dose of 250 milligrams (mg) of recombinant Human Chorionic Gonadotropin (r-hCG) will be administered subcutaneously at 12 hours after the last injection of lutropin alfa and/or follitropin alfa and analogous GnRH antagonist.
干预措施: r-hCG (Drug)
r-FSH + r-hLH
Lutropin alfa (r-hLH) will be administered at a daily dose of 150 International Units (IU) from the presence of at least one follicle greater than (>) 14 millimeter (mm) to complete ovarian stimulation. Follitropin alfa (r-FSH) will be administered at an initial dose of 225-450 IU per day (according to standard center practice); the dose will then be adjusted to ovarian response as assessed by ovarian ultrasound and/or serum estradiol. Participants will also receive analogous GnRH antagonist and natural progesterone, as per standard center practice. To complete follicular maturation and trigger ovulation, a single dose of 250 milligrams (mg) of recombinant Human Chorionic Gonadotropin (r-hCG) will be administered subcutaneously at 12 hours after the last injection of lutropin alfa and/or follitropin alfa and analogous GnRH antagonist.
干预措施: Progesterone (Drug)
r-FSH
Follitropin alfa (r-FSH) will be administered at an initial dose of 225-450 IU per day (according to standard center practice); the dose will then be adjusted to ovarian response as assessed by ovarian ultrasound and/or serum estradiol. Participants will also receive analogous GnRH antagonist and natural progesterone, as per standard center practice. To complete follicular maturation and trigger ovulation, a single dose of 250 mg of r-hCG will be administered subcutaneously at 12 hours after the last injection of follitropin alfa and analogous GnRH antagonist.
干预措施: r-FSH (Drug)
r-FSH
Follitropin alfa (r-FSH) will be administered at an initial dose of 225-450 IU per day (according to standard center practice); the dose will then be adjusted to ovarian response as assessed by ovarian ultrasound and/or serum estradiol. Participants will also receive analogous GnRH antagonist and natural progesterone, as per standard center practice. To complete follicular maturation and trigger ovulation, a single dose of 250 mg of r-hCG will be administered subcutaneously at 12 hours after the last injection of follitropin alfa and analogous GnRH antagonist.
干预措施: Analogous GnRH antagonist (Drug)
r-FSH
Follitropin alfa (r-FSH) will be administered at an initial dose of 225-450 IU per day (according to standard center practice); the dose will then be adjusted to ovarian response as assessed by ovarian ultrasound and/or serum estradiol. Participants will also receive analogous GnRH antagonist and natural progesterone, as per standard center practice. To complete follicular maturation and trigger ovulation, a single dose of 250 mg of r-hCG will be administered subcutaneously at 12 hours after the last injection of follitropin alfa and analogous GnRH antagonist.
干预措施: r-hCG (Drug)
r-FSH
Follitropin alfa (r-FSH) will be administered at an initial dose of 225-450 IU per day (according to standard center practice); the dose will then be adjusted to ovarian response as assessed by ovarian ultrasound and/or serum estradiol. Participants will also receive analogous GnRH antagonist and natural progesterone, as per standard center practice. To complete follicular maturation and trigger ovulation, a single dose of 250 mg of r-hCG will be administered subcutaneously at 12 hours after the last injection of follitropin alfa and analogous GnRH antagonist.
干预措施: Progesterone (Drug)
结局指标
主要结局
Number of Oocytes Retrieved
时间窗: At the end of stimulation (Day 2 up to Day 8)
Oocytes Recovery Rate
时间窗: At the end of stimulation (Day 2 up to Day 8)
Oocytes recovery rate (oocytes per \>14 mm follicle) is defined as number of oocytes retrieved divided by number of follicles \>14 mm in diameter.
Number of Follicles Greater Than (>) 14 Millimeter (mm) in Diameter
时间窗: At the end of stimulation (Day 2 up to Day 8)
次要结局
- Number of Embryos by Quality(Up to 35-45 days after administration of r-hCG (r-hCG administration = Day 2 to Day 8))
- Fertilization Rate(Up to 35-45 days after administration of r-hCG (r-hCG administration = Day 2 to Day 8))
- Number of Embryos Transferred by In Vitro Fertilization (IVF)(Up to 35-45 days after administration of r-hCG (r-hCG administration = Day 2 to Day 8))
- Number of Participants With Positive Pregnancy Test(Up to 35-45 days after administration of r-hCG (r-hCG administration = Day 2 to Day 8))
- Duration of Ovarian Stimulation(Randomization to Day 8)
- Oocyte Nuclear Maturity Rate(At the end of stimulation (Day 2 up to Day 8))
- Number of Participants in Whom At Least 1 Stimulation Cycle Was Cancelled(Randomization to Day 8)
- Plasma Level of Estradiol(At the time of r-hCG administration (any days between Day 2 to Day 8))
- Endometrial Thickness(At the time of r-hCG administration (any days between Day 2 to Day 8))
- rFSH Cumulative Dose(Randomization to Day 8)
- Number of Participants With Clinical Pregnancy(Up to 35-45 days after administration of r-hCG (r-hCG administration = Day 2 to Day 8))
- Implementation Rate(Up to 35-45 days after administration of r-hCG (r-hCG administration = Day 2 to Day 8))
- Plasma Levels of LH(At the time of r-hCG administration (any days between Day 2 to Day 8))