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

February 15, 2016 updated by: Erkan Kalafat, Ankara University

Effects of Laparoscopic Endometrioma Removal on Anti-mullerian Hormone Levels

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

102

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

This study will recruit healthy women besides having endometrioma cysts who will undergo laparoscopic removal of such lesions.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anti-Mullerian hormone levels
Time Frame: 1 year
AMH (anti-mullerian hormone) levels will be measured before surgery and during various time points up to 1 year after the surgery
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ankara University

Investigators

  • Principal Investigator: Erkan Kalafat, Ankara University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (Anticipated)

September 1, 2018

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

February 15, 2016

First Submitted That Met QC Criteria

February 15, 2016

First Posted (Estimate)

February 19, 2016

Study Record Updates

Last Update Posted (Estimate)

February 19, 2016

Last Update Submitted That Met QC Criteria

February 15, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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