jRCT2031250671招募中不适用
A parallel-group treatment, 2-arm study to compare the efficacy andsafety of follitropin alfa and lutropin alfa fixed dose combinationversus hMG for inducing follicular development in Japaneseparticipants with LH and FSH deficiency undergoing ART (HINATA)
未提供0 个研究点目标入组 333 人开始时间: 待定
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 333
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
入排标准
- 年龄范围
- 18age old over 至 42age old under（—）
- 性别
- Female
入选标准
- •Participants who are premenopausal wishing to conceive-Participants with maximum 1 previous stimulation for assistedreproductive technology (ART) without pregnancy
- •Japanese Participants
- •Participants are women with FSH and LH deficiency congenital oracquired
- •Participants have a vaginal ultrasound scan showing both ovariesand no clinically significant uterine abnormality and a normal antralfollicle count (AFC) of at least 5 follicles 2 to 10 millimeter (mm) indiameter per ovary
- •A semen analysis of the male partner been performed within3 months prior to signature of informed consent and suitablefor ART
- •Participants have a normal cervical ThinPrep cytologic test, (TCT) orPap smear within 12 monthsof Screening. If not available, a cervical smear will beperformed as part of screening
- •Other protocol defined criteria may apply
排除标准
- •Participants with history of severe OHSS in any previous ovarianstimulation cycle
- •Participants with Polycystic ovarian syndrome (PCOS) according toRotterdam modified definition
- •Participants with contraindication to treatment with gonadotropins,hypersensitivity to gonadotropins or to any of the excipients
- •Participants with presence of known or suspected gonadotropin- or estrogen dependent malignancy (example. ovarian-, uterine-, ormammary carcinoma)
- •Participants with ovarian enlargement or cyst of unknown etiology,orpresence of an ovarian cyst greater than > 25 mm before Day 1
- •other protocol defined exclusion criteria may apply
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