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

Sponsor

Ankara University (Other)

Overall Status

Unknown status

CT.gov ID

NCT02685644

Collaborator

(none)

102

Enrollment

Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Endometriosis Ovarian Reserve	Procedure: Laparoscopic removal of cysts

Study Design

Study Type:

Observational

Anticipated Enrollment :

102 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Effects of Laparoscopic Endometrioma Removal on Anti-mullerian Hormone Levels

Study Start Date :

Apr 1, 2016

Anticipated Primary Completion Date :

Sep 1, 2018

Anticipated Study Completion Date :

Dec 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Laparoscopic removal Patients with endometrioma who will undergo laparoscopic removal of cysts.	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.

Arm

Intervention/Treatment

Laparoscopic removal

Patients with endometrioma who will undergo laparoscopic removal of cysts.

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.

Outcome Measures

Primary Outcome Measures

Anti-Mullerian hormone levels [1 year]
AMH (anti-mullerian hormone) levels will be measured before surgery and during various time points up to 1 year after the surgery

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 35 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Ankara University

Investigators

Principal Investigator: Erkan Kalafat, Ankara University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Erkan Kalafat, Research Assistant, Ankara University

ClinicalTrials.gov Identifier:

NCT02685644

Other Study ID Numbers:

First Posted:

Feb 19, 2016

Last Update Posted:

Feb 19, 2016

Last Verified:

Feb 1, 2016

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Keywords provided by Erkan Kalafat, Research Assistant, Ankara University

endometrioma

laparoscopy

anti-mullerian hormone

ovarian reserve

Additional relevant MeSH terms:

Endometriosis

Study Results

No Results Posted as of Feb 19, 2016