NCT01735422已完成2 期
A Phase II, Single Center, Open, Randomized, Parallel Group, Dose Finding Study to Assess the Safety and Efficacy of Recombinant Human Luteinizing Hormone (r-hLH), Compared With Urinary Human Chorionic Gonadotrophin (u-hCG), in Inducing Ovulation in Infertile Women Undergoing Stimulation of Follicular Development With Recombinant Human Follicle Stimulating Hormone (Gonal F®).
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 67
- 试验地点
- 1
- 主要终点
- Ovulation rate
研究概览
简要总结
This is a single center, open-label, randomized, parallel group, dose finding study to evaluate safety and efficacy of recombinant human luteinizing hormone (r-hLH, LHadi®), compared with urinary human chorionic gonadotrophin (u-hCG, Profasi®), both given subcutaneously, in inducing ovulation in infertile women undergoing stimulation of follicular growth with recombinant human follicle stimulating hormone (r-hFSH, Gonal-F®).
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
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Infertile woman wishing to conceive and justifying ovarian stimulation treatment with gonadotrophins for in vivo conception
- •Aged 20-40 years (inclusive)
- •Male partner with acceptable semen analysis for intra-uterine insemination, according to center's standard practice
- •Have the following hormone serum levels measured locally during early (Day 2-4) follicular phase (if menstruating) or at anytime (if not menstruating):
- •Follicle stimulating hormone (FSH) less than 12 international unit per liter (IU/L)
- •Prolactin (PRL) less than 800 milli international unit per liter (mIU/l)
- •Lutenizing hormone (LH), P4, Testosterone (T) and Dehydroepiandrosterone sulphate (DHEA-S) for documentation purposes
- •At least one patent tube, as assessed with hysterosalpingography (HSG), ultrasound (U/S) or laparoscopy performed within 3 years prior to beginning r-hFSH treatment
- •Uterine cavity without abnormalities which, in the Investigator's opinion, could impair embryo implantation or pregnancy evolution as assessed with HSG, hysteroscopy (HSC) or U/S performed within 3 years prior to beginning r-hFSH treatment
- •Body mass index (BMI) greater than or equal to 18 and less than or equal to 35 kilogram per square meter (kg/m^2)
- •Negative serum or urinary pregnancy test prior to beginning r-hFSH treatment
- •Be willing and able to comply with the protocol for the duration of the study
- •Have given written informed consent, prior to any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care
排除标准
- •Any contraindication to being pregnant and/or carrying a pregnancy to term
- •Clinically significant systemic disease (screening for Human Immunodeficiency Virus (HIV) and Hepatitis B and C surface antigens had to be performed to confirm eligibility, unless data obtained within one year prior to beginning r-hFSH treatment was available)
- •Any medical condition which in the judgment of the Investigator's and sponsor may have interfered with the absorption, distribution, metabolism or excretion of the study drug
- •Persistent ovarian cyst with a mean diameter larger than 20 mm or ovarian endometrioma, as assessed with U/S performed prior to beginning r-hFSH treatment
- •Severe endometriosis (American Fertility Society Classification Stage III or IV)
- •World health organization (WHO) Group I anovulation
- •Pelvic inflammatory disease within 1 year prior to beginning r-hFSH treatment
- •Treatment with clomiphene citrate or gonadotrophins within 1 month prior to beginning r-hFSH treatment
- •Abnormal undiagnosed gynecological bleeding
- •Known allergy or hypersensitivity to human gonadotrophins preparations
- •Known or current substance abuse
- •Previous participation in this study or simultaneous participation in another clinical trial
研究组 & 干预措施
r-hLH (825 International Units [IU])
Experimental
干预措施: r-hFSH (Drug)
r-hLH (825 International Units [IU])
Experimental
干预措施: r-hLH (Drug)
r-hLH (2750 IU)
Experimental
干预措施: r-hFSH (Drug)
r-hLH (2750 IU)
Experimental
干预措施: r-hLH (Drug)
r-hLH (5500 IU)
Experimental
干预措施: r-hFSH (Drug)
r-hLH (22000 IU)
Experimental
干预措施: r-hFSH (Drug)
r-hLH (5500 IU)
Experimental
干预措施: r-hLH (Drug)
r-hLH (11000 IU)
Experimental
干预措施: r-hFSH (Drug)
r-hLH (11000 IU)
Experimental
干预措施: r-hLH (Drug)
r-hLH (22000 IU)
Experimental
干预措施: r-hLH (Drug)
u-hCG (5000 IU)
Active Comparator
干预措施: r-hFSH (Drug)
u-hCG (5000 IU)
Active Comparator
干预措施: u-hCG (Drug)
结局指标
主要结局
Ovulation rate
时间窗: Day 4 post r-hLH/u-hCG day (end of stimulation cycle [approximately 28 days])
Ratio of ruptured follicles per follicle with diameter greater than or equal to (>=) 15 millimeter (mm)
时间窗: Day 4 post r-hLH/u-hCG day (end of stimulation cycle [approximately 28 days])
Number of follicles with diameter greater than or equal to (>=) 11 millimeter (mm)
时间窗: Day 4 post r-hLH/u-hCG day (end of stimulation cycle [approximately 28 days])
Ratio of ruptured follicles per follicle with diameter greater than or equal to (>=) 11 millimeter (mm)
时间窗: Day 4 post r-hLH/u-hCG day (end of stimulation cycle [approximately 28 days])
次要结局
- Serum estradiol (E2) levels(Day 1, 2 and 6-9 post r-hLH/u-hCG day (end of stimulation cycle [approximately 28 days]))
- Number of participants with biochemical pregnancy(Day 25-30 post r-hLH/u-hCG day (end of stimulation cycle [approximately 28 days]))
- Serum total renin levels(Day 1, 2 and 6-9 post r-hLH/u-hCG day (end of stimulation cycle [approximately 28 days]))
- Serum vascular endothelial growth factor (VEGF) levels(Day 1, 2 and 6-9 post r-hLH/u-hCG day (end of stimulation cycle [approximately 28 days]))
- Serum androstenedione levels(Day 1, 2 and 6-9 post r-hLH/u-hCG day (end of stimulation cycle [approximately 28 days]))
- Endometrial thickness(Day 0, 1, 2, 3, 4 and 6-9 post r-hLH/u-hCG day (end of stimulation cycle [approximately 28 days]))
- Percentage of participants with mono-follicular ovulation(Day 4 post r-hLH/u-hCG day (end of stimulation cycle [approximately 28 days]))
- Number of participants with clinical pregnancy(Day 25-30 post r-hLH/u-hCG day (end of stimulation cycle [approximately 28 days]))
- Serum progesterone (P4) levels(Day 1, 2 and 6-9 post r-hLH/u-hCG day (end of stimulation cycle [approximately 28 days]))
研究者
研究点 (1)
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