Impact of Different Hemostasis Methods on Ovarian Function and Fertility During Laparoscopic Ovarian Cystectomy of Benign Ovarian Cyst
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 165
- 试验地点
- 1
- 主要终点
- Antral Follicle Count (AFC)
研究概览
简要总结
The purpose of this study is to compare the impact of different hemostasis methods during laparoscopic ovarian cystectomy on ovarian function and fertility in women with benign ovarian cysts.
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women diagnosed with benign ovarian cysts requiring surgical management.
- •Women who choose laparoscopic ovarian cystectomy voluntarily sign a surgical consent form.
- •Women participating in this study recognize three hemostatic methods and are ready to randomly accept one of them.
- •Women aged between 18 and 40 years old.
- •It was diagnosed by ultrasound as unilateral or bilateral benign ovarian cysts with a maximum diameter of 4-8cm. The nature of the cysts is ultimately confirmed by postoperative pathological examination.
- •Women with no previous history of ovarian surgery, chemotherapy, or pelvic radiation therapy.
- •Patients with no history of endocrine disorders such as hyperprolactinemia, hypothyroidism, or hyperthyroidism, and no history of endocrine therapy within 6 months before laparoscopic ovarian cystectomy.
排除标准
- •Polycystic ovary syndrome.
- •Pregnancy or lactation period.
- •Women with active pelvic inflammatory disease, genital or extragenital malignant tumors.
- •Women who have undergone two or more pelvic or abdominal surgeries.
- •Evidence of premature ovarian failure or premature menopause, such as AMH<1ng/ml.
- •Conversion to open surgery.
- •Women who refuse to sign informed consent or are unable to attend follow-up regularly.
- •Cysts that do not originate from the ovaries or have the characteristics of malignant tumors.
结局指标
主要结局
Antral Follicle Count (AFC)
时间窗: Preoperative quantity and postoperative quantity for 1, 3, and 6 months
Antral follicle count (AFC) generally refers to the basic follicles in ovaries, which have not yet begun to develop. If the number of AFC is within the normal range (usually 5-10), it indicates that the ovarian reserve function is normal. If the number is low, it generally means that the ovarian reserve function is relatively low. If the number is high, it may be caused by polycystic ovary syndrome. Besides, AFC can be detected through ultrasound examination, and the number of AFC can directly reflect the ovarian reserve of each ovary.
次要结局
- Anti-Mullerian hormone (AMH)(Preoperative level and postoperative level at 1, 3, and 6 months)
研究者
Yanru Long
Resident physician
West China Second University Hospital