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临床试验/NCT03615352
NCT03615352已完成不适用

Impact of Laparoscopic Ovarian Cystectomy Versus Aspiration and Coagulation on Ovarian Reserve and Pelvic Pain in Cases of Ovarian Endometrioma

Shaimaa Mostafa Mohammed Refaay El shemy2 个研究点 分布在 1 个国家目标入组 92 人开始时间: 2018年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
92
试验地点
2
主要终点
Exploration of the impact of laparoscopic ovarian cystectomy versus aspiration and coagulation on Anti Mullerian hormone (AMH) as a measurement of ovarian reserve .

研究概览

简要总结

The aim of this study is to evaluate the impact of laparoscopic ovarian cystectomy versus aspiration and coagulation on ovarian reserve and pelvic pain in cases of ovarian endometrioma.

详细描述

All patients are presenting with ovarian endometrioma. They are all subjected to informed written consent, full history, general examination, local examination and transvaginal ultrasound. Follicular stimulating hormone (FSH), Lutenizing hormone (LH), Anti Mullerian hormone (AMH), Antral follicular count (AFC) and chronic pelvic pain which is assessed by Visual Analogue Scale (VAS) of pain scoring system ,all are to be determined before and after laparoscopic surgery (postoperative three months); for two groups (Group A) cystectomy and (Group B) aspiration and coagulation. Histopathological examination was done to the cystectomy group to confirm endometriosis and detect the presence of healthy ovarian tissue in the excised cyst wall.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Single (Participant)

入排标准

年龄范围
20 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Female with age group 20-40 years.
  • Female diagnosed by ultrasound with unilateral ovarian endometrioma ≥3cm.

排除标准

  • Previous ovarian surgery.
  • Endocrinological diseases affecting ovarian reserve e.g. Diabetes mellitus, hypothyroidism.
  • Polycystic ovary syndrome (PCO).
  • Suspicion of ovarian malignancy by ultrasound.
  • Other pelvic pathology e.g. uterine fibroid, pelvic inflammatory disease (PID).
  • High basal FSH >10mIU/mL (milli-international unit per milliliter).

研究组 & 干预措施

ovarian cystectomy

Experimental

laparoscopic ovarian cystectomy in endometrioma

干预措施: ovarian cystectomy (Procedure)

ovarian cyst aspiration and coagulation

Experimental

laparoscopic ovarian endometrioma aspiration and coagulation

干预措施: ovarian cyst aspiration and coagulation (Procedure)

结局指标

主要结局

Exploration of the impact of laparoscopic ovarian cystectomy versus aspiration and coagulation on Anti Mullerian hormone (AMH) as a measurement of ovarian reserve .

时间窗: 3 months after laparoscopy

Evaluation of ovarian reserve which is measured by Anti Mullerian hormone (AMH) in nano-gram per milliliter (ng/ml) before laparoscopy and after the surgery by 3 months.

次要结局

  • Exploration of the impact of laparoscopic ovarian cystectomy versus aspiration and coagulation on Antral Follicular Count (AFC) as a measurement of ovarian reserve.(3 months after laparoscopy)
  • Exploration of the impact of laparoscopic ovarian cystectomy versus aspiration and coagulation on chronic pelvic pain.(3 months after laparoscopy)

研究者

发起方
Shaimaa Mostafa Mohammed Refaay El shemy
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Shaimaa Mostafa Mohammed Refaay El shemy

Assistant lecturer of Obstetrics and Gynecology, Kasr Al ainy Hospital

Cairo University

研究点 (2)

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