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

Endometriosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02754648
• Other study ID #: Ain ShamsU Laparoscopic Unit
• Status: Active, not recruiting
• Phase: N/A
• First received: March 16, 2016
• Last updated: April 26, 2016
• Start date: September 2015
• Est. completion date: September 2016

Study information

• Verified date: April 2016
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Health and Population
• Study type: Interventional

Clinical Trial Summary

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?

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 90
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Endometriosis

Intervention

Procedure:
• laparoscopic ovarian endometriotic cyst

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes
Secondary	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	Yes