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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02685644
Recruitment Status : Not yet recruiting
First Posted : February 19, 2016
Last Update Posted : February 19, 2016
Information provided by (Responsible Party):
Erkan Kalafat, Ankara University

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
Endometriosis Ovarian Reserve Procedure: Laparoscopic removal of cysts

Study Type : Observational
Estimated Enrollment : 102 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effects of Laparoscopic Endometrioma Removal on Anti-mullerian Hormone Levels
Study Start Date : April 2016
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

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.

Primary Outcome Measures :
  1. 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

Biospecimen Retention:   Samples Without DNA
Blood serum samples

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02685644

Contact: Erkan Kalafat

Sponsors and Collaborators
Ankara University
Principal Investigator: Erkan Kalafat Ankara University

Responsible Party: Erkan Kalafat, Research Assistant, Ankara University Identifier: NCT02685644     History of Changes
Other Study ID Numbers: 07
First Posted: February 19, 2016    Key Record Dates
Last Update Posted: February 19, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by Erkan Kalafat, Ankara University:
anti-mullerian hormone
ovarian reserve

Additional relevant MeSH terms:
Genital Diseases, Female
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs