Surgery Before Embryo Transfer in Endometrioma Related Reduction in Ovarian Reserve
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Positive b-hCG Rate
研究概览
简要总结
This prospective study evaluates the pregnancy results after laparoscopic endometriosis operation in infertile patients with ERROR (endometrioma related reduction in ovarian reserve)
详细描述
This study consists of two groups. Patients will be randomly enrolled into the groups by ART (assisted reproductive technology) centre nursery. All patients will sign a consent form about procedure.
Patients diagnosed with endometrioma (larger than 3 cm diameter) and ERROR (endometrioma related reduction in ovarian reserve - Antimullerian Hormon < 1.2 ng/ml, Antral follicle count < 7 , Day3 Follicle Stimulating Hormone > 10 IU/dl, Low response to ovarian hyper stimulation < 3 oocytes) will be enrolled in study. Patients with age >40, with male factor, with undefined adnexal mass, malignity suspicion will be excluded from study.
The study group consists of patients who will undergo laparoscopic endometriosis surgery after ICSI procedure with freezing all embryos. The patients will wait about 6 months for spontaneous conception, if there is no pregnancy during this period, frozen embryo transfer will be performed. The control group consists of patients who will be performed IVF&ICSI procedure with fresh embryo transfer without surgery. If there is no pregnancy, patients will be operated then.
As the primary; result positive b-hCG rates will be compared between groups.
In conclusion we will find out whether laparoscopic endometriosis operation improves or worsens the pregnancy results in patients with ERROR.
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
- 23 Years 至 40 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Presence of Endometrioma at least in one ovary, larger than 3 cm diameter
- •Endometriosis Related Reduction in Ovarian Reserve (ERROR)
- •Presence of endometriosis related infertility
排除标准
- •Presence of chronic systemic disease
- •Presence of male factor infertility
- •Suspicion of ovarian malignancy or undefined ovarian mass
结局指标
主要结局
Positive b-hCG Rate
时间窗: 6 months
Postoperative 6. months positive b-hCG rates will be compared with control group.
次要结局
未报告次要终点
研究者
GÜRKAN UNCU,PROF. MD
Prof. Dr.
Uludag University
