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临床试验/NCT03585309
NCT03585309Unknown不适用

The Impact of Electrocoagulation on Ovarian Reserve After Laparoscopic Excision of Ovarian Cysts: Randomization Clinical Trial

Ain Shams University1 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2018年7月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
96
试验地点
1
主要终点
Number of participants (Females) with ovarian cyst or dermid cyst or endometrial

研究概览

简要总结

The aim of the study is to evaluate the effect of bipolar electrocoagulation on ovarian reserve.

详细描述

Laparoscopic ovarian cystectomy is currently considered the treatment of choice in women with benign ovarian cysts and has gained increasing acceptance among gynecologic sur¬geons . However, the safety of this technique in terms of ovarian damage to the operated gonad has recently been questioned. A great deal of evidence supports that the re¬moval of ovarian cysts is associated with injury to the ovarian reserve . Many of these studies involved patients who required assisted reproduction, and they found that the number both of follicles and retrieved oocytes obtained in the operated gonad during ovarian hyperstimulation was markedly reduced when compared with the contralateral intact ovary. However, most of these studies applied ovarian response to gonadotropin hyperstimulation to measure the ovarian reserve. It has been argued that these patients are not representative of all patients undergoing laparoscopic ovarian cystectomy in terms of ovarian damage because these data were acquired from aggressive gonadotropin stimulation which is thought to be different from a natural menstrual cycle .

On the other hand, because ovarian reserve cannot be mea¬sured directly, the evaluation of ovarian reserve is difficult to carry out. The induction of ovarian hyperstimulation in an un¬selected population of surgical patients for the purpose of evaluating ovarian reserve is obviously ethically untenable. The serum level of follicle-stimulating hormone (FSH) is a predictor of functional ovarian reserve , but its usefulness is limited considering that the vast majority of patients un¬dergo monolateral excision of a cyst and the contralateral in¬tact gonad may completely substitute for reduced function of the operated ovary . Given the well-established role of ul¬trasound scanning in the diagnosis and follow-up of ovarian cysts, reported that basal antral follicle number and mean ovarian diameter could be used as indicators of ovarian reserve. found that the value of ovarian stromal blood flow velocity was an initial marker of ovarian reserve before the change of FSH level and ovarian volume.

With the combined use of serum hormonal evaluation and ultrasound examination, the investigators prospectively investigated the ovarian reserve of patients after the excision of benign ovarian cysts. The damage to ovarian reserve was evaluated during through a 12-month follow-up period after the application of bipolar, ultrasonic scalpel electrocoagulation or suture for ovarian cystectomy .

研究设计

研究类型
Interventional
干预模型
Sequential
主要目的
Treatment
盲法
None

入排标准

年龄范围
20 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •Age: 20-35 years.
  • •Uni-bilateral ovarian cyst(s) size without clinical and sonographic suspicion of ovarian cancer.
  • •Regular menstrual cycles defined as a cycle length between 25 and 35 days in the 6 months before surgery.
  • •Agreement to be enrolled in the study.
  • •Endometriosi.
  • •Renal disesase.
  • •Liver disease.

排除标准

  • •1- Prior ovarian surgery 2- Surgical necessity to perform adnexectomy 3- Known endocrine disease 4- Postoperative pathologic diagnosis that was not benign ovarian cyst 5- Oral contraceptive use before surgery last two months. 6-Addison disease. 7.Thyroid disease.

研究组 & 干预措施

Laparascopy comper with coagulation and without coagulation

Experimental

干预措施: The impact of electrocoagulation on ovarian reserve after laparoscopic excision of ovarian cysts: (Procedure)

结局指标

主要结局

Number of participants (Females) with ovarian cyst or dermid cyst or endometrial

时间窗: 3 months after surgery

Laparascopy without coagulation excision of ovarian cysts and effect of ovarian reserve RESULIT The result of the study is to evaluate the effect of bipolar electrocoagulation on ovarian reserve.

次要结局

  • Number of participants (Females) with ovarian cyst or dermid cyst or endometrial(3 months after surgery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Zahra Hussein Mohammed Chewai

Resident of obstetrics and gynecology

Ain Shams University

研究点 (1)

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