NCT05311059

Brief Summary

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

  • 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 .

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 30, 2018

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 4, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 7, 2020

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

March 8, 2022

Completed
28 days until next milestone

First Posted

Study publicly available on registry

April 5, 2022

Completed
Last Updated

February 12, 2024

Status Verified

February 1, 2024

Enrollment Period

1.7 years

First QC Date

March 8, 2022

Last Update Submit

February 9, 2024

Conditions

Polycystic Ovary Syndrome

Outcome Measures

Primary Outcomes (2)

  • 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

    3 months from laparoscopy

  • AntiMullerian hormone

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

    3 months from laparoscopy

Study Arms (1)

Ovarian drilling

EXPERIMENTAL

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

Procedure: Laparoscopic ovarian drilling

Interventions

Laparoscopic ovarian drillingPROCEDURE

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

Ovarian drilling

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kasr Alainy medical school

Cairo, 12151, Egypt

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Study Officials

  • Ahmed Maged, MD

    Cairo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

March 8, 2022

First Posted

April 5, 2022

Study Start

May 30, 2018

Primary Completion

February 4, 2020

Study Completion

March 7, 2020

Last Updated

February 12, 2024

Record last verified: 2024-02

Locations

EG(1)