Effect of Myomectomy for Intramural Myoma on Fertility Outcomes in Infertile Women: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 3
- 主要终点
- Clinical pregnancy rate
研究概览
简要总结
The aim of this study is to evaluate the effect of myomectomy for intramural myomas on the fertility outcomes in infertile women.
详细描述
All women participating in the study will be randomly allocated into two groups; myomectomy group and conservative management group. Women in the myomectomy group will be subjected to laparotomy to remove the myomas while women in the conservative management group will not be subjected to surgery. Women in the myomectomy group will be asked to abstain from having sexual intercourse (or use a barrier contraception method) for 3 months after surgery then to start having regular fertility-oriented intercourse after that. Women in the conservative management group will be asked to immediately start having regular fertility-oriented intercourse. Women in both groups will be monitored form the time of starting regular intercourse and for one year for occurrence of clinical pregnancy.
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
- 20 Years 至 33 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Infertility for at least one year.
- •Presence of intramural myoma.
- •Absence of any other cause of infertility as revealed by basic infertility work up including laparoscopy.
排除标准
- •Age is < 20 or > 33 years.
- •Symptomatic fibroid causing pelviabdominal swelling.
- •Presence of > 2 myomas.
- •Presence of a coexisting another type of myoma other than intramural myoma (e.g. submucosal, subserosal, cervical or ligamentary myoma).
- •Presence of any other cause of infertility.
结局指标
主要结局
Clinical pregnancy rate
时间窗: 6-8 weeks gestational age
Number of clinical pregnancies (defined as presence of at least one intrauterine gestational sac with fetal pole and cardiac activity on TVS scan at 6-8 weeks gestational age) divided by the number of women
次要结局
- Miscarriage rate(12 weeks gestational age)