Comparison of Crinone ® Versus Combination Medication for Luteal Phase Support on the Ongoing Pregnancy Rate of Frozen-thawed Cycle in Chinese Population a Randomized, Interventional, Open-label, Phase IV, Single Center, Pilot Study (ACCESS)
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 172
- 试验地点
- 1
- 主要终点
- Ongoing Pregnancy Rate
研究概览
简要总结
The study to compare to the efficacy and safety of Crinone versus combination medication in infertile women receive frozen-thawed embryo transfer (FET) in artificial cycles (AC).
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 38 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Participants are eligible to be included in the study only if all the following criteria apply:
- •Participants who will receive artificial frozen-thawed embryo transfer (FET) cycle study interventions
- •Participants who have no more than two Day 5 embryos are planned to be transferred (follow the clinical practice of the study site)
- •Participants have received estradiol valerate for no more than 20 days
- •Participants have a transitional-endometrium of greater than or equal to 8 millimeter
- •Participants have normal uterine cavity
- •Participants can give signed informed consent
- •Participants are willing to follow the study protocol and able to complete the study
排除标准
- •Participants are willing to follow the study protocol and able to complete the study
- •Participants with greater than or equal to three previously failed cycles of ET
- •Participants with diseases that cannot tolerate pregnancy
- •Hydrosalpinx
- •Severe endometriosis (Endometriosis American Society for Reproductive Medicine (ASRM) criteria from 1996)
- •Known hypersensitivity to progesterone, the excipients of Crinone and Duphaston Vaginal bleeding of unknown origin
- •History of recurrent miscarriages
- •Vaginitis
- •Thromboembolic diseases (thrombophlebitis, thromboembolic disorder, or cerebral apoplexy) or participants with a history of these conditions
- •Known or suspected progestogen-dependent neoplasm
- •Participation in another clinical trial within the past 30 days
- •Contraindications of both Crinone and Duphaston
研究组 & 干预措施
Crinone
Participants received Crinone 8% (90 milligrams [mg] an intravaginal progesterone gel contained in a single use, one piece applicator) once daily in morning from the day of endometrial transformation (Day -5) until ongoing pregnancy was confirmed up to Day 63.
干预措施: Crinone (Drug)
Crinone plus Duphaston
Participants received Crinone 8% (90 mg an intravaginal progesterone gel contained in a single use, one piece applicator) once daily in morning followed by 10 mg of Duphaston tablet orally twice a day from the day of endometrial transformation (Day -5) until ongoing pregnancy was confirmed up to Day 63.
干预措施: Crinone (Drug)
Crinone plus Duphaston
Participants received Crinone 8% (90 mg an intravaginal progesterone gel contained in a single use, one piece applicator) once daily in morning followed by 10 mg of Duphaston tablet orally twice a day from the day of endometrial transformation (Day -5) until ongoing pregnancy was confirmed up to Day 63.
干预措施: Duphaston (Drug)
结局指标
主要结局
Ongoing Pregnancy Rate
时间窗: 8 to 10 weeks after embryo transfer
Ongoing pregnancy was assessed by the presence of viable intra uterine fetus detected by ultrasound examination in 10-12 weeks of pregnancy (8 to 10 weeks after embryo transfer). Ongoing pregnancy rate is defined as the number of participants with ongoing pregnancy divided by the number of participants with embryo transfer (ET) multiplied by 100.
次要结局
- Early Abortion Rate(Time from embryo transfer to 12 weeks of pregnancy)
- Vaginal Bleeding Rate(5 and 9 weeks after embryo transfer)
- Beta Human Chorionic Gonadotrophin (Beta-hCG) Positive Rate(2 weeks after embryo transfer)
- Implantation Rate(4-6 weeks after embryo transfer)
- Clinical Pregnancy Rate(4-6 weeks after embryo transfer)
- Luteal Phase Bleeding Rate(2, 5 and 9 weeks after embryo transfer)