Unilateral Versus Bilateral Laparoscopic Ovarian Drilling In Clomiphene Citrate (CC) Resistant Cases of Polycystic Ovarian Syndrome (PCOS): A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 130
- 试验地点
- 2
- 主要终点
- Restoration of ovulation
研究概览
简要总结
The aim of the current study is to compare the efficacy of laparoscopic unilateral ovarian drilling with bilateral ovarian drilling in clomiphene citrate resistant cases of polycystic ovarian syndrome in terms of clinical response (regularity of the cycle), change in biochemical parameters, ovulation rate over six months, pregnancy rate within six months.
详细描述
Polycystic ovary syndrome (PCOS), is considered the most common endocrine disorder in reproductive age in females. Polycystic ovary syndrome (PCOS) is characterized by reproductive and metabolic disturbances. Androgen excess is a hallmark of polycystic ovary syndrome (PCOS), driving many of the phenotypic features
The clinical response to laparoscopic ovarian drilling (LOD) seems to be thermal energy dose-dependent. Two punctures (300 J) per ovary are associated with poor results. Between three and five (450-750 J) punctures per ovary seem to represent the effective thermal dose. The application of six or more (C900 J) punctures per ovary may result in excessive destruction to the ovary and should therefore be discouraged.
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
- 25 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age within 25-35 years.
- •Polycystic ovarian syndrome as diagnosed according to modified Rotterdam criteria 2018: oligomenorrhea or amenorrhea; clinical and/or biochemical signs of hyperandrogenism; and transvaginal sonographic appearance of polycystic ovaries (≥ 20 follicles or an ovarian volume 10 cm3) .
- •Infertile women who have clomiphene citrate -resistant polycystic ovary syndrome (150 mg/daily for 5 days for six cycles with no ovulation).
- •Normal semen analysis in the husband.
排除标准
- •Hyper-androgenic disorders like late onset congenital adrenal hyperplasia, hyperprolactinemia, thyroid diseases.
- •Cushing's syndrome and androgen-secreting tumors.
- •Body mass index > 30 kg/m
- •Other medical problems like diabetes, Hypertesion, patients on steroid hormone .... etc.
- •Other causes of infertility as multiple uterine fibroids.
结局指标
主要结局
Restoration of ovulation
时间窗: 6 month after operation.
Restoration of ovulation was measured before operation and for 6 month after operation .
次要结局
- Folliculometry(6 month after operation.)
- Anti-müllerian hormone(AMH)(6 month after operation.)
- Follicle-stimulating hormone (FSH)(6 month after operation.)
- Luteinizing hormone (LH)(6 month after operation.)
- Pregnancy rate(6 month after operation.)
研究者
Sahar Saeed Ahmed Elhalfawy
Resident of Obstetrics and Gynecology department, Ebiar central hospital, Faculty of Medicine, University of Tanta, Tanta, AL Gharbia ,
Tanta University