NCT01923194已完成3 期
A Randomized, Assessor-blinded, Parallel Group, Multi-center, Non-inferiority Study Investigating the Efficacy and Safety of Highly Purified Urofollitropin for Injection Compared to Recombinant Human Follitropin Alfa for Injection for Ovulation Induction Using a Low-dose, Step-up Protocol in Chinese Females With WHO Group II Anovulatory Infertility Failing to Conceive on Clomiphene Citrate
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 215
- 试验地点
- 12
- 主要终点
- The ovulation rate defined as the percentage of subjects who present ovulation
研究概览
简要总结
Evaluate the Efficacy and Safety of Highly Purified Urofollitropin for Injection Compared to Recombinant Human Follitropin Alfa for Injection for Ovulation Induction in Chinese females
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 39 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent form prior to screening evaluations
- •Chinese females between the ages of 20-39 years
- •Infertility for at least 1 year before screening
- •Women WHO type II anovulatory infertility with chronic anovulation (defined as amenorrhoea (i.e., no menstrual bleeding for 6 months or more) or oligoamenorrhoea (i.e., cycles of more than 35 days) ) with progestogen induced withdrawal bleeding or spontaneous menstrual bleeding
- •Failure to conceive after at least one cycle of ovulation induction with clomiphene citrate
- •Bilateral tubal patency documented by a hysterosalpingography or sonohysterography or laparoscopy within 2 years prior to screening
- •Normal pelvis documented by a transvaginal ultrasound with respect to uterus, Fallopian tubes and ovaries within 3 months prior to screening
- •Early follicular phase serum levels of FSH within normal limits (1-12 IU/L,) (results obtained within 2 months prior to randomization)
- •LH (Luteinizing hormone), prolactin , E2 (estradiol), progesteron, total testosterone, and TSH (thyrotropin) levels within normal limits for the clinical laboratory
- •Male partner with a semen analysis obtained within 12 months prior to randomisation and showing acceptable values for semen according to the local laboratory, or showing more than 2.000.000 progressive motile sperm per mL after capacitation (in case of IUI (intrauterine insemination))
- •BMI (Body mass index) is ≥ 18.5 and < 30 kg/m2
排除标准
- •Any known clinically significant systemic disease
- •Known past or current thrombophlebitis or thromboembolism including venous thrombosis disease and active or recent arterial thrombosis disease
- •Any known endocrine or metabolic abnormalities which can compromise participation in the trial with the exception of controlled thyroid function disease
- •Any known concomitant medications that would interfere with evaluation of study medications. Specifically, any non-study hormonal therapy (except for thyroid medication), anti-psychotics, anxiolytics, hypnotics and sedatives, and need for continuous use of prostaglandin inhibitors (non-steroid anti- inflammatory drugs (NSAIDs), including aspirin) at the time of study entry.
- •Known history of 12 or more unsuccessful (no pregnancy achieved) ovulation induction cycles
- •Any known treatment with clomiphene citrate, metformin, gonadotropins or GnRH analogues within one month prior to randomisation
- •Ovarian cysts with a mean diameter ≥ 15 mm that have persisted for more than one cycle or ovarian endometrioma on ultrasound
- •Known at least one previous cycle experienced luteinized unruptured follicle syndrome
- •Known abnormal results of cervical examination of clinical significance obtained within 1 years prior to screening
- •Abnormal vaginal bleeding of undetermined origin
- •Known tumors of the ovary, breast, uterus, adrenal gland, pituitary or hypothalamus
- •Known malformations of the sexual organs incompatible with pregnancy
- •Known current or past (last 12 months) abuse of alcohol or drugs
- •Known history of chemotherapy (except for gestational conditions) or radiotherapy
- •Finding of any clinically relevant abnormal laboratory value
- •Use of any non registered investigational drugs during 3 months before screening or previous participation in the study
- •Pregnancy, lactation or contraindication to pregnancy
研究组 & 干预措施
Test Group
Experimental
干预措施: Highly Purified Urofollitropin (Drug)
Comparator Group
Active Comparator
干预措施: Recombinant Human Follitropin Alfa (Drug)
结局指标
主要结局
The ovulation rate defined as the percentage of subjects who present ovulation
时间窗: From 6 days up to 7 weeks post hCG (human chorionic gonadotropin) administration
次要结局
- Endometrial thickness(On the day of hCG administration)
- Total FSH (Follicle-stimulating hormone) dose administered(On the day of hCG administration)
- Frequency and severity of injection site reactions(Day 1 up to Day 28 of the ovarian stimulation period)
- The positive serum progesterone rate(6~9 days post hCG administration)
- The clinical pregnancy rate(6~7 weeks post hCG administration)
- The follicular development(On the day of hCG administration)
- The ongoing pregnancy rate(11~12 weeks post hCG administration)
- The positive serum β-hCG/hCG rate(18~22 days post hCG administration)
- Frequency and severity of adverse events(Expected maximum of 6 months)
- Number of FSH treatment days(On the day of hCG administration)
- Serum estradiol (E2) levels(On the day of hCG administration)
研究者
研究点 (12)
Loading locations...
相似试验
已完成
3 期
Evaluation of Efficacy and Safety of Highly Purified Urofollitropin in Chinese Females Undergoing an Assisted Reproductive Technology (ART) ProgramInfertilityNCT01922193Ferring Pharmaceuticals263
已完成
4 期
Efficacy of Corifollitropin Alfa Versus Follitropin Beta in Aged IVF (In-vitro Fertilization) PatientsInfertilityNCT02466204Vietnam National University400
已完成
1 期
Pharmacokinetics, Safety, Tolerability, and Immunogenicity of Two Formulations of SB5 in Healthy Male SubjectsHealthyNCT04514796Samsung Bioepis Co., Ltd.188
已完成
3 期
A Study to Compare Subcutaneous Versus Intravenous Administration of RoActemra/Actemra (Tocilizumab) in Participants With Moderate to Severe Active Rheumatoid ArthritisRheumatoid ArthritisNCT01194414Hoffmann-La Roche1,262
已完成
2 期
BI 10773 add-on to Metformin in Patients With Type 2 DiabetesDiabetes Mellitus, Type 2NCT00749190Boehringer Ingelheim495