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

Polycystic Ovary Syndrome Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05311059
• Other study ID #: 64
• Status: Completed
• Phase: N/A
• Start date: May 30, 2018
• Est. completion date: March 7, 2020

Study information

• Verified date: February 2024
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 7, 2020
• Est. primary completion date: February 4, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome
• Syndrome

Intervention

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

Locations

Country	Name	City	State
Egypt	Kasr Alainy medical school	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	AntiMullerian hormone	Plasma samples were assayed for AMH in duplicate using a commercial enzyme-linked immunosorbant assay kit.	3 months from laparoscopy