EUCTR2013-003788-67-BE进行中（未招募）不适用
A Randomised, Parallel Group, Assessor-Blind, Multicentre Study to Compare the Safety and Efficacy of Watson rhFSH with Follitropin Alfa (GONAL-f) in Stimulating Multiple Follicular Development in Women Participating in an Assisted Reproductive Technology Program.
Watson Laboratories, Inc. - A subsidiary of Actavis, Inc.0 个研究点目标入组 471 人开始时间: 2013年12月19日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 471
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •IN01. Is in good health and 18 to 35 years of age (inclusive) with child-bearing potential at the time of screening;
- •IN02. Has a body mass index (BMI) of 18 – 32 (inclusive);
- •IN03. Has adequate ovarian reserve as measured by: a) the serum FSH level during the early follicular phase (menstrual cycle day 2, 3 or 4) is less than 2x the upper range of normal for the study population at Screening and b) the serum anti-Mullerian hormone (AMH) level is between 1.0 to 4.5 ng/mL (i.e., 1.0 ng/mL < AMH < 4.5 ng/mL) at Screening;
- •IN04. Has a current diagnosis of infertility with one of the following categories: tubal factor, ovulation disorder, mild endometriosis (American Society for Reproductive Medicine [ASRM] stage 1-2), male factor, other causes, unexplained cause, multiple factors (female only), and multiple factors (male and female);
- •IN05. Has both ovaries (by ultrasonography at Screening) and normal uterine cavity;
- •IN06. Has a male partner with semen analysis that is at least adequate for ICSI within 6 months before the first test or reference article injection (Surgically-removed or donor sperm, if adequate for ICSI, is allowed.);
- •IN07. Has LH, prolactin (PRL), thyroid stimulating hormone (TSH) results within the reference range for the clinical laboratory or considered not clinically significant by the Investigator at Screening;
- •IN08. Has current general health status that is congruent with the site’s conventional requirements for ART eligibility;
- •IN09. Is willing and able to comply with the requirements of the protocol;
- •IN10. Is willing and able to provide written informed consent and authorisation to disclose after being fully informed of the risks of participating in the study.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 96
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •EX01. Has participated in another study protocol or in a clinical trial with experimental medication within 30 days of Screening;
- •EX02. Has participated in previous ART cycle before this study;
- •EX03. Has taken clomiphene, tamoxifen, injectable GnRH agonists or antagonists, estrogen, androgens, anti-androgens, synthetic progestins, or aromatase inhibitors within 30 days of Screening;
- •EX11. Has 12 or more follicles in either ovary, size 2 - 9 mm in diameter (calculated as the mean of the longitudinal and anteroposterior diameters) and/or an ovarian volume > 10 mL in either ovary (calculated using the formula 0.5 x length x width x thickness), as determined by transvaginal ultrasound examination at Screening Visit 3
- •or on Treatment Day 1 before the first test or reference article injection;
- •EX12. Has symptoms or signs of pelvic or vaginal infection or abnormal gynecological bleeding;
- •EX13. Has current diagnosis of or signs and symptoms that indicate adrenal dysfunction;
- •EX14. Has a history of recurrent spontaneous abortion (3 or more);
- •EX15. Has a history of extrauterine pregnancy in the past 6 months before Screening;
- •EX16. Has a history of allergy or hypersensitivity to any protein based drugs, including FSH and hCG products and GnRH antagonists, or any excipient in the formulation of the test or reference articles;
- •EX17. Is a smoker with an average > 5 cigarettes (or equivalent tobacco use of other types) a day;
- •EX18. Is unable or unwilling to tolerate injections;
- •EX19. Is judged by the Investigator to be unsuitable for enrollment for any other reason.
研究者
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