Three Different Laparoscopic Approaches for Ovarian Endometrioma and the Effect on Ovarian Reserve

Is ovarian reserve and fecundity rate higher with laparoscopic ovarian aspiration rather than laparoscopic ovarian cystectomy and laparoscopic ovarian de-roofing in infertile woman with ovarian endometrioma or not?

Study Overview

• Status: Unknown
• Conditions: Endometriosis
• Intervention / Treatment: Procedure: laparoscopic ovarian endometriotic cyst

Detailed Description

Primary objective:

To assess antral follicular count before and after treatment of endometriotic cyst either by aspiration, stripping, de-roofing and bed cauterization.

Secondary objectives To assess anti mullerian hormone level, follicle stimulating hormone level ,Doppler blood flow before and after treatment of endometriotic cyst either by aspiration, stripping, de-roofing and bed cauterization.

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Infertile woman aged 18-35 years old.
• Endometriotic ovarian cyst with size less than or equal 5 cm.

Exclusion Criteria:

• Other than included criteria.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group A; laparoscopic ovarian endometrial aspiration; Laparoscopic ovarian endometrial aspiration will be done for thirty patients with ovarian endometriotic cyst. .	Procedure: laparoscopic ovarian endometriotic cyst
Active Comparator: group B; laparoscopic ovarian endometrial stripping; Laparoscopic ovarian endometrial stripping will be done for thirty patients with ovarian endometriotic cyst.	Procedure: laparoscopic ovarian endometriotic cyst
Active Comparator: Group c laparoscopic ovarian endometrial de-roofing; Laparoscopic ovarian endometrial de-roofing and bed cauterization will be done for thirty patients with ovarian endometriotic cyst.	Procedure: laparoscopic ovarian endometriotic cyst

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The antral follicular count which records the number of visible ovarian follicle (2-10 mm mean diameter) seen by transvaginal ultrasound on menstrual cycle( days 2_5)	Cut point(3-10)	One month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anti mullerian hormone level in blood secreted by antral follicles 2-6 mm diameter in ovary	Measure in ng/ml cut point is( 0.2-0.7)	One month
Follicle stimulating hormone in blood secreted by antral follicles on day 2-4 of menstrual cycle	Cut point is(10-20) measured in international unit/litre	One month

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Anticipated): September 1, 2016
• Study Completion (Anticipated): September 1, 2016

Study Registration Dates

• First Submitted: March 16, 2016
• First Submitted That Met QC Criteria: April 26, 2016
• First Posted (Estimate): April 28, 2016

Study Record Updates

• Last Update Posted (Estimate): April 28, 2016
• Last Update Submitted That Met QC Criteria: April 26, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endometriosis
• Other Study ID Numbers: Ain ShamsU Laparoscopic Unit

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO