The Effect of Laparoscopic Surgery on Ovarian Reserve According to Cyst Types

September 3, 2022 updated by: Sabahattin Anıl Arı, Ege University
The aim of our study is to compare the effect of laparoscopic ovarian cystectomy on ovarian reserve in terms of different cyst types.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Participants who will be treated surgically for ovarian cysts will be included in the study. Anti-Mullerian Hormone (AMH) levels of the participants will be investigated before the surgery and 6 months after the surgery. All surgeries will be performed under general anesthesia laparoscopically. After histopathological evaluation, the participants will be divided into three groups; Group 1: Endometrioma, Group 2: Mature cystic teratoma (Dermoid cyst) and Group 3: Serous or mucinous cystadenoma.

A total of fifty-five women will be included in the study.

Study Type

Interventional

Enrollment (Actual)

55

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • İzmir, Turkey, 35100
        • Ege University Hospital

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 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • no ovarian surgery before

Exclusion Criteria:

  • Endocrinological pathologies
  • Suspicion of malignancy in preoperative laboratory and ultrasonographic evaluations
  • Detection of malignancy in histopathological examination

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

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Endometrioma
Participants who will have endometrioma after histopathological evaluation.
Procedure: Laparoscopic cystectomy
All surgeries will be performed under general anesthesia by laparoscopically.
Active Comparator: Mature cystic teratoma (dermoid cyst)
Participants who will have mature cystic teratoma (dermoid cyst) after histopathological evaluation.
Procedure: Laparoscopic cystectomy
All surgeries will be performed under general anesthesia by laparoscopically.
Active Comparator: Serous or mucinous cystadenoma
Participants who will have serous or mucinous cystadenoma after histopathological evaluation.
Procedure: Laparoscopic cystectomy
All surgeries will be performed under general anesthesia by laparoscopically.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in AMH Level
Time Frame: 6 months
AMH levels of the participants will be investigated before the surgery and 6 months after the surgery.
6 months

Collaborators and Investigators

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

Sponsor

Ege University

Investigators

  • Principal Investigator: Sabahattin Anil Ari, MD, Ege 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 (Actual)

October 1, 2021

Primary Completion (Actual)

September 1, 2022

Study Completion (Actual)

September 1, 2022

Study Registration Dates

First Submitted

September 19, 2021

First Submitted That Met QC Criteria

September 19, 2021

First Posted (Actual)

September 23, 2021

Study Record Updates

Last Update Posted (Actual)

September 7, 2022

Last Update Submitted That Met QC Criteria

September 3, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17/056

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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