Impact of Laparoscopic Endometrioma Stripping Surgery on Fertility: Pre- Operative and Post- Operative Changes of Serum Anti-mullerian Hormone Levels
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 3
- 主要终点
- Change of antral follicular count (AFC)
研究概览
简要总结
To compare changes in follicular ovarian reserve in women before and six months after laparoscopic operation: endometrioma stripping surgery. Also, to compare follicular ovarian reserve in women with endometrioma(s) with follicular ovarian reserve of healthy infertile women of the same age group.
详细描述
In order to investigate the impact of laparoscopic stripping surgery on follicular ovarian reserve, blood samples will be obtained before the operation, from 2nd to 5th day of the menstrual cycle, to determine levels of endocrine markers of ovarian reserve (FSH, E2, AMH and Inhibin B). Cancer antigen 125 (CA -125) and IL-6 will be measured also. US markers (antral follicular count- AFC) will be obtained at the same time as endocrine markers. All laparoscopic stripping surgery will be performed during the early or middle follicular phases of menstrual cycle, under general anesthesia, by the same team of gynecological endoscopist. The cyst wall will be completely stripped off from the normal ovarian tissue by traction and opposite traction with two grasping forceps. Hemostasis will be achieved using bipolar forceps electrocoagulation. All endometrioma specimens that will be obtained from operation will be submitted for pathology examination. One and six months after the laparoscopic cystectomy, from 2nd to 5th day of menstrual cycle, we will determine endocrine markers of ovarian reserve and levels of CA 125 and IL-6.
The control group will be consisted of healthy women with infertility problem. From the second to the fifth day of the menstrual cycle we will take blood samples to determinate endocrine markers of follicular ovarian reserve: AMH, FSH, E2, Inhibin B.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 42 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Study group: Women with endometrioma(s)
- •Age: 18- 42 years of age
- •Regular menstrual cycles defined as cycle length between 25- 35 days
- •Ultrasound made diagnosis of endometrioma unilateral or bilateral ≥4 cm in diameter.
- •Laparoscopically and histologically confirmed diagnosis.
- •Agreement to be enrolled in the study
- •Control group: Healthy reproductive aged women with tubal, unexplained or male infertility.
排除标准
- •Previous ovarian surgery
- •Suspicious of malignancy
- •Known endocrine disorder or other chronic diseases.
- •Use of oral contraceptive drug, gonadotropin- releasing hormone (GnRH) agonist/ antagonist, or other drugs related with ovarian function in at least 3 months before surgery.
结局指标
主要结局
Change of antral follicular count (AFC)
时间窗: 2nd to 5th day of the cycle in which laparoscopy is performed and 2nd to 5th day of the cycle in 6th month after laparoscopy
as the US marker of ovarian reserve
Change of Inhibin B levels
时间窗: 2nd to 5th day of the cycle in which laparoscopy is performed and 2nd to 5th day of the cycle in 6th month after laparoscopy
as the endocrine marker of ovarian reserve
Change of follicle-stimulating hormone (FSH)
时间窗: 2nd to 5th day of the cycle in which laparoscopy is performed and 2nd to 5th day of the cycle in 6th month after laparoscopy
as the endocrine marker of ovarian reserve
Change of estradiol (E2) levels
时间窗: 2nd to 5th day of the cycle in which laparoscopy is performed and 2nd to 5th day of the cycle in 6th month after laparoscopy
as the endocrine marker of ovarian reserve
Change of Anti-mullerian hormone (AMH) levels
时间窗: 2nd to 5th day of the cycle in which laparoscopy is performed and 2nd to 5th day of the cycle in 6th month after laparoscopy
as the endocrine marker of ovarian reserve
次要结局
- Change of interleukin-6 (IL-6) levels(2nd to 5th day of the cycle in which laparoscopy is performed and 2nd to 5th day of the cycle in 6th month after laparoscopy)
- Change of CA -125 levels(2nd to 5th day of the cycle in which laparoscopy is performed and 2nd to 5th day of the cycle in 6th month after laparoscopy)
研究者
Svetlana Spremovic- Radjenovic
Professor of Gynecology and Obstetrics
Clinical Centre of Serbia