NCT04124913Unknown4 期
Comparison of Oral Dydrogesterone Versus Micronized Vaginal Progesterone for Luteal Phase Support in Frozen-thawed Embryo Transfer Cycles: a Randomized Controlled Trial
Memorial Sisli Hospital, Istanbul1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2019年1月2日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Ongoing pregnancy rate
研究概览
简要总结
The aim of this randomized controlled trial is to compare the efficacy of oral dydrogesterone vs. micronized vaginal progesterone for luteal phase support in frozen-thawed embryo transfer cycles.
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 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Ages between 20 and 40
- •Modified natural frozen- thawed embryo transfer cycles
排除标准
- •Recurrent implantation failure
- •Recurrent pregnancy loss
- •Presence of uterine pathology
研究组 & 干预措施
Dydrogesterone
Experimental
干预措施: Dydrogesterone 10 MG Oral Tablet (Drug)
Vaginal progesterone
Active Comparator
干预措施: Progesterone Vaginal Gel [Crinone] (Drug)
结局指标
主要结局
Ongoing pregnancy rate
时间窗: 12 weeks after the last menstrual period of the patient
Presence of at least one live fetus at the end of the 12th gestational week
次要结局
- Clinical pregnancy rate(6-7 weeks after the last menstrual period of the patient)
- Biochemical pregnancy(10 days after embryo transfer)
- Biochemical miscarriage(before 5th gestational week)
- Clinical miscarriage(after 5th gestational week)
- headache rate(6-7 weeks after the last menstrual period of the patient)
- Implantation rate(5 weeks after the last menstrual period of the patient)
- interference with coitus rate(6-7 weeks after the last menstrual period of the patient)
- somnolence rate(6-7 weeks after the last menstrual period of the patient)
- dizziness rate(6-7 weeks after the last menstrual period of the patient)
- nausea/vomiting rate(6-7 weeks after the last menstrual period of the patient)
- vaginal discharge rate(6-7 weeks after the last menstrual period of the patient)
- perineal irritation rate(6-7 weeks after the last menstrual period of the patient)
- abdominal pain rate(6-7 weeks after the last menstrual period of the patient)
- mastalgia rate(6-7 weeks after the last menstrual period of the patient)
- vaginal bleeding rate(6-7 weeks after the last menstrual period of the patient)
- interference with intercourse rate(6-7 weeks after the last menstrual period of the patient)
- overall satisfaction score(6-7 weeks after the last menstrual period of the patient)
研究者
Gönül Özer
Medical doctor
Memorial Sisli Hospital, Istanbul
研究点 (1)
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