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

Primary Purpose

Polycystic Ovary Syndrome

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Laparoscopic ovarian drilling
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Polycystic Ovary Syndrome

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Kasr Alainy medical school

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ovarian drilling

Arm Description

Outcomes

Primary Outcome Measures

Antral follicular count
AFC is defined as counting of all echo lucent rounded follicles measuring (2-10mm) that present in the substance of the ovary
AntiMullerian hormone
Plasma samples were assayed for AMH in duplicate using a commercial enzyme-linked immunosorbant assay kit.

Secondary Outcome Measures

Full Information

First Posted
March 8, 2022
Last Updated
March 27, 2022
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05311059
Brief Title
Impact of Laparoscopic Ovarian Drilling on Ovarian Reserve in Patients With Anovulatory Polycystic Ovarian Syndrome
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
May 30, 2018 (Actual)
Primary Completion Date
February 4, 2020 (Actual)
Study Completion Date
March 7, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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: 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 .
Detailed Description
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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ovarian drilling
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic ovarian drilling
Intervention Description
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 Outcome Measure Information:
Title
Antral follicular count
Description
AFC is defined as counting of all echo lucent rounded follicles measuring (2-10mm) that present in the substance of the ovary
Time Frame
3 months from laparoscopy
Title
AntiMullerian hormone
Description
Plasma samples were assayed for AMH in duplicate using a commercial enzyme-linked immunosorbant assay kit.
Time Frame
3 months from laparoscopy

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Kasr Alainy medical school
City
Cairo
ZIP/Postal Code
12151
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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