Does Myomectomy for Intramural Fibroid Improve ART Outcome? A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- The primary outcome will be ongoing pregnancy rate
研究概览
简要总结
Intamural fibroids (myoma) do exist in some infertile women undergoing IVF treatment. There is controversy whether myomectomy before IVF treatment could improve IVF outcome. This trial will examine whether myomectomy in those patients could improve the results.
详细描述
This study will include women who have intramural myoma ranging from 3-5 cm
The participants will be randomly allocated into two groups.
In group (1): myomectomy will be performed before ART
In group (2):women will have their trial of ART without myomectomy
In group A, ART will be performed 3 months after myomectomy if the uterine cavity is not opened and 6 months after myomectomy upon inadvertent opening of the uterine cavity during surgery
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 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Inclusion criteria:
- •Women with intramural fibroid without any cavity involvement
- •Age ˂ 35 years
- •I onCSI or IVF cycles
- •normal uterine cavity
排除标准
- •Exclusion criteria:
- •low ovarian reserve (AFC < 7 and or AMH < 1.1 ng/ml)
- •Endometrioma
- •Untreated hydrosalpinx
- •Non obstructive azoospermia
- •Any other cavitary lesions (Asherman syndrome, Mullerian anomalies)
- •recurrent implantation failure
结局指标
主要结局
The primary outcome will be ongoing pregnancy rate
时间窗: 3 months after embryo transfer
Pregnancy continued after 12 week gestation per randomised women
次要结局
- -Implantation rate(15 days after embryo transfer)
- -clinical pregnancy rate(5 weeks after embryo transfer)
研究者
Ahmed Gibreel
Assistant professor
Mansoura University