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NCT02685644 Clinical Trial

Association Between Laparoscopic Removal of Endometriomas and Anti-mullerian Hormone Levels

Endometriosis Clinical Trial

Official title:
Effects of Laparoscopic Endometrioma Removal on Anti-mullerian Hormone Levels

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT02685644
Other study ID # 07
Secondary ID
Status Not yet recruiting
Phase N/A
First received February 15, 2016
Last updated February 15, 2016
Start date April 2016
Est. completion date December 2018

Study information
Verified date February 2016
Source Ankara University
Contact Erkan Kalafat
Email ekalafat@ankara.edu.tr
Is FDA regulated No
Health authority Turkey: Ministry of Health
Study type Observational

Clinical Trial Summary

Laparoscopic excision of endometriotic cysts is the main stream surgical intervention for treatment of endometriosis. However there is evidence that intervention may effect ovarian reserve by destruction of healthy ovarian tissue during surgery. Available evidence on the topic are contradictory and employed research methodology are diverse. There is need for an adequately powered research with proper methodology to assess actual effects of surgery.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 102
Est. completion date December 2018
Est. primary completion date September 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 35 Years
Eligibility Inclusion Criteria:

- Women with endometrioma cyst(s)

- Women of age under 35 years old

- Women without any previous ovarian surgery

Exclusion Criteria:

- Combined oral contraceptive or long term GnRH (gonadotropin-releasing hormone) analog use in the preceding 3 months to enrolment

- Having another cystic lesion besides endometrioma

- Need for extensive bipolar coagulation during surgery

- Any anatomical problem preventing evaluation of ovaries with high-resolution ultrasound

- Postoperative pathology excluding endometrioma

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Procedure:
• Laparoscopic removal of cysts
Women with endometrioma lesions will undergo laparoscopic removal. Cysts will be enucleated with blunt dissection of the cyst capsule and following traction, counter traction maneuver. Bipolar coagulation will be used sparsely and suturing will be the predominant choice for achieving bleeding control.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Ankara University

Outcome
Type Measure Description Time frame Safety issue
Primary Anti-Mullerian hormone levels AMH (anti-mullerian hormone) levels will be measured before surgery and during various time points up to 1 year after the surgery 1 year No
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