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

Sponsor
Cairo University (Other)
Overall Status
Completed
CT.gov ID
NCT05311059
Collaborator
(none)
50
1
1
21.3
2.4

Study Details

Study Description

Brief Summary

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 .

Condition or Disease Intervention/Treatment Phase
  • Procedure: Laparoscopic ovarian drilling
N/A

Detailed Description

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 .

Study Design

Study Type:
Interventional
Actual Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official 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
Actual Study Start Date :
May 30, 2018
Actual Primary Completion Date :
Feb 4, 2020
Actual Study Completion Date :
Mar 7, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Ovarian drilling

Procedure: Laparoscopic ovarian 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

Outcome Measures

Primary Outcome Measures

  1. Antral follicular count [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 [3 months from laparoscopy]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 35 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Kasr Alainy medical school Cairo Egypt 12151

Sponsors and Collaborators

  • Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ahmed M Maged, MD, professor, Cairo University
ClinicalTrials.gov Identifier:
NCT05311059
Other Study ID Numbers:
  • 64
First Posted:
Apr 5, 2022
Last Update Posted:
Apr 5, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 5, 2022