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Completed

NCT Number: NCT05311059

Impact of Laparoscopic Ovarian Drilling on Ovarian Reserve in Patients With Anovulatory Polycystic Ovarian Syndrome

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 .

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Key information

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Kasr Alainy medical school

Cairo, 12151, Egypt

About this study

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

  • Needle test: Verress needle patency check.
  • Hissing phenomenon: Needle introduced by open valve mechanism.
  • Aspiration test: Placing a drop of water on the opening of the needle and examine its disappearance into the abdomen.
  • 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 .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • o Age below 18y or above 35.
  • Ovulatory PCO.
  • Responder to Clomiphene citrate.
  • Obvious cause of infertility rather than PCO.
  • Hyperandrogenism due to any other endocrinal disorder

Treatment and study plan

Laparoscopic ovarian drilling

Procedure

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

Primary outcomes

  1. Antral follicular count

    Time frame: 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

  2. AntiMullerian hormone

    Time frame: 3 months from laparoscopy

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

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Apr 5, 2022
Registry last updated
Feb 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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