Endometrial Injury Versus Luteal Phase Support in Intrauterine Insemination Cycles
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 118
- 试验地点
- 1
- 主要终点
- Pregnancy Rate
研究概览
简要总结
The investigators will try to assess the effect of endometrial injury preceding the intrauterine insemination cycle on the pregnancy rates compared to cycles with luteal phase support and the control group.
详细描述
Group 1: Endometrial biopsy is performed on days 21-24 of the spontaneous menstrual cycle proceeding the intrauterine insemination (IUI) treatment cycle. Two small biopsies are obtained from anterior and posterior walls of the uterus.
Group 2: Vaginal progesterone gel is administered for luteal phase support from second day after insemination until pregnancy testing and is continued in the presence of pregnancy until the 12 weeks of pregnancy.
Goup 3: Patients are undergone intrauterine insemination (IUI) cycles stimulated with gonadotropin without any intervention.
The effect of endometrial injury and luteal phase progesterone support on the pregnancy rate in patients intrauterine insemination (IUI) cycles stimulated with gonadotropin will be compared in terms of biochemical pregnancy rate, clinical pregnancy rate and ongoing pregnancy rate.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Patients are undergone intrauterine insemination with gonadotropin stimulation
- •Bilateral patent fallopian tubes revealed by hysterosalpingography or laparoscopy
- •After semen preparation for intrauterine insemination, total progressive sperm count > 5 million
排除标准
- •endocrin or metabolic disorders,
- •uterine factor,
- •pelvic inflammatory disease,
- •women with basal follicle-stimulating hormone (FSH) level >15 IU/mL,
- •body mass index (BMI) ≥ 35 kg/m2,
- •age ≥ 40 and < 18 years,
研究组 & 干预措施
Endometrial Injury
Endometrial injury in luteal phase of preceding IUI cycle
干预措施: Endometrial Injury (Other)
Luteal Phase Support
Luteal phase support with progesterone (Crinone® %8 vaginal progesterone gel) in IUI cycle Vaginal progesterone gel is administered from second day after insemination until pregnancy testing and is continued in the presence of pregnancy until the 12 weeks of pregnancy.
干预措施: progesterone (Crinone® %8 vaginal progesterone gel) (Drug)
结局指标
主要结局
Pregnancy Rate
时间窗: 12 weeks
ongoing pregnancy rates
次要结局
未报告次要终点
研究者
Selcuk Selcuk
Medical Doctor
Zeynep Kamil Maternity and Pediatric Research and Training Hospital