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

NCT ID: NCT02685644

Last Updated: 2016-02-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

102 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-04-30

Study Completion Date

2018-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Endometriosis Ovarian Reserve

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Laparoscopic removal

Patients with endometrioma who will undergo laparoscopic removal of cysts.

Laparoscopic removal of cysts

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Ankara University

OTHER

Sponsor Role lead

Responsible Party

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Erkan Kalafat

Research Assistant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Erkan Kalafat

Role: PRINCIPAL_INVESTIGATOR

Ankara University

Central Contacts

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Erkan Kalafat

Role: CONTACT

Other Identifiers

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07

Identifier Type: -

Identifier Source: org_study_id

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