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临床试验/NCT05311059
NCT05311059已完成不适用

Impact of Laparoscopic Ovarian Drilling on Ovarian Reserve (Serum Anti-mullerian Hormone Levels - Antral Follicular Count and Ovarian Volume) in Patients With Anovulatory Polycystic Ovarian Syndrome

Cairo University2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2018年5月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
2
主要终点
AntiMullerian hormone

研究概览

简要总结

Pneumoperitoneum is done by insertion of the verress needle at the inferior edge of the umbilicus putting into consideration the following tests:

  1. Needle test: Verress needle patency check.
  2. Hissing phenomenon: Needle introduced by open valve mechanism.
  3. Aspiration test: Placing a drop of water on the opening of the needle and examine its disappearance into the abdomen.
  4. Volume test: Changes occurred in the intra abdominal pressure during gas insufflations.

Intra abdominal pressure 12-16 mmHg usually suitable for this pelvic surgery. Introduction of the laparoscopic instruments all in its place

  • Laparoscopic telescope : From the inferior edge of umbilicus through trocar and sleeve which inserted by corkscrew technique then removed to allow the telescope insertion which connected to light source , camera head and color monitor.
  • 2nd and 3rd punctures were done allowing another two graspers to be inserted usually at a point represent outer 1/3 of the lateral abdominal wall in an imaginary line from umbilicus to iliac bone

Puncturing technique :

Fixation of one ovary away from intestine by grasping the ovarian ligament with the traumatic grasper which allow good exposure of the ovary and allow drilling .

Drilling needle was introduced and connected by monopolar current, held against ovarian surface for 4 seconds using a power of 40 watt, 4 puncture was done in each ovary with putting into consideration that the puncture must be not superficial and it must go deep through the main substance of the ovary.

Cooling of the ovary by lactated ringer's solution, finally removal of all instruments under vision after exclusion of any complication .

详细描述

Pneumoperitoneum is done by insertion of the verress needle at the inferior edge of the umbilicus putting into consideration the following tests:

  1. Needle test: Verress needle patency check.
  2. Hissing phenomenon: Needle introduced by open valve mechanism.
  3. Aspiration test: Placing a drop of water on the opening of the needle and examine its disappearance into the abdomen.
  4. Volume test: Changes occurred in the intra abdominal pressure during gas insufflations.

Intra abdominal pressure 12-16 mmHg usually suitable for this pelvic surgery. Introduction of the laparoscopic instruments all in its place

  • Laparoscopic telescope : From the inferior edge of umbilicus through trocar and sleeve which inserted by corkscrew technique then removed to allow the telescope insertion which connected to light source , camera head and color monitor.
  • 2nd and 3rd punctures were done allowing another two graspers to be inserted usually at a point represent outer 1/3 of the lateral abdominal wall in an imaginary line from umbilicus to iliac bone.

Puncturing technique :

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • o Age of woman: 18 - 35 y.
  • Anovulatory PCO.
  • Clomiphene citrate resistant Woman:
  • Full dose of Clomiphene citrate.
  • 6 Months of ovarian induction.
  • Normal semen analysis and Hystrosalpingography

排除标准

  • o Age below 18y or above
  • Ovulatory PCO.
  • Responder to Clomiphene citrate.
  • Obvious cause of infertility rather than PCO.
  • Hyperandrogenism due to any other endocrinal disorder

结局指标

主要结局

AntiMullerian hormone

时间窗: 3 months from laparoscopy

Plasma samples were assayed for AMH in duplicate using a commercial enzyme-linked immunosorbant assay kit.

Antral follicular count

时间窗: 3 months from laparoscopy

AFC is defined as counting of all echo lucent rounded follicles measuring (2-10mm) that present in the substance of the ovary

次要结局

未报告次要终点

研究者

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

Ahmed M Maged, MD

professor

Cairo University

研究点 (2)

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