Phase III Clinical Trial Comparing the Efficacy and Safety of DA-3803(Recombinant Human Chorionic Gonadotrophin) and Ovidrel for Inducting Final Follicular Maturation and Early Luteinization in Women Undergoing Ovulation
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 3
- 主要终点
- the efficacy and safety of DA-3803(r-hCG)
研究概览
简要总结
The purpose of this study is to compare the efficacy and safety of DA-3803(r-hCG) and Ovidrel for inducting final follicular maturation and early luteinization in women undergoing ovulation induction for assisted reproduction treatment
详细描述
This is an single-blind, randomized, comparative multicentric, phase III study to evaluate the safety and efficacy of DA-3803(r-hCG) in comparison with Ovidrel in the induction of final follicle maturation and early luteinization in 180 Korean female subjects undergoing superovulation. The study is organized on an outpatient basis in subjects undergoing assisted reproductive technologies (ART). The subjects are randomized into 2 groups. One group receive DA-3803(r-hCG) 250mcg and the other group receive Ovidrel®(r-hCG)250mcg. Each subject in both groups receives a single injection of hCG when the follicular development was judged to be adequate. Oocytes are retrieved 34-38 hours after r-hCG injection and fertilized in vitro. Not more than 4 embryos are to be replaced. Progesterone is administered daily according to center's normal practice, starting after the oocyte pick up and continuing until appropriate time. The subject is followed up and the treatment outcome (negative pregnancy test or pregnancy) is recorded.
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 (Participant)
入排标准
- 年龄范围
- 20 Years 至 38 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Infertility regular ovulatory menstrual cycles : 25~35days
- •BMI<=30kg/m2
- •Early follicular phase serum levels are normal : FSH, LH, prolactin, testosterone
- •Both ovaries present and clinically normal uterine cavity
- •< 3 previous ART cycles, no ART cycles for 2 menstrual cycles
- •semen analysis and ART are possible
- •informed couple consent
排除标准
- •With a poor response to gonadotrophin stimulation, such as ≤3 oocytes collected in any previous ART cycle
- •Had previous severe ovarian hyperstimulation syndrome(OHSS)
- •Polycystic ovarian syndrome(PCOS)
- •Extra-uterine pregnancy within the last 3 months
- •A clinically significant uncontrolled endocrine diseases, chronic cardiovascular disorders, hepatic, pulmonary and renal diseases
- •Known allergy,hypersensitivity or contraindication to FSH, hCG, progesterone and GnRH antagonists
- •medication with human gonadotrophin preparations(FSH, LH, hCG) within 2 months
- •participation in another clinical trial within 1 month
研究组 & 干预措施
DA-3803
subjects treated with DA-3803(r-hCG)
干预措施: r-hCG (Drug)
Ovidrel
subjects treated with Ovidrel(r-hCG)
干预措施: r-hCG (Drug)
结局指标
主要结局
the efficacy and safety of DA-3803(r-hCG)
时间窗: about 1 month after ART
the number of oocytes retrieved per patient following r-hCG administration, physical examination, clinical laboratory measurements, adverse events, injection-sited reactions, OHSS, number of multiple pregnancies
次要结局
- the efficacy of DA-3803(r-hCG)(about 1 month after ART)