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

Primary Purpose

Ovarian Cysts

Status

Completed

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

Laparoscopic cystectomy

About this trial

This is an interventional treatment trial for Ovarian Cysts focused on measuring ovarian reserve, anti-mullerian hormone, ovarian cyst

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Ege University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

Endometrioma

Mature cystic teratoma (dermoid cyst)

Serous or mucinous cystadenoma

Arm Description

Participants who will have endometrioma after histopathological evaluation.

Participants who will have mature cystic teratoma (dermoid cyst) after histopathological evaluation.

Participants who will have serous or mucinous cystadenoma after histopathological evaluation.

Outcomes

Primary Outcome Measures

Change in AMH Level

AMH levels of the participants will be investigated before the surgery and 6 months after the surgery.

Secondary Outcome Measures

Full Information

NCT ID

NCT05054946

First Posted

September 19, 2021

Last Updated

September 3, 2022

Sponsor

Ege University

1. Study Identification

Unique Protocol Identification Number

NCT05054946

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Completed

Study Start Date

October 1, 2021 (Actual)

Primary Completion Date

September 1, 2022 (Actual)

Study Completion Date

September 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ege University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The aim of our study is to compare the effect of laparoscopic ovarian cystectomy on ovarian reserve in terms of different cyst types.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ovarian Cysts

Keywords

ovarian reserve, anti-mullerian hormone, ovarian cyst

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

55 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Endometrioma

Arm Type

Active Comparator

Arm Description

Participants who will have endometrioma after histopathological evaluation.

Arm Title

Mature cystic teratoma (dermoid cyst)

Arm Type

Active Comparator

Arm Description

Participants who will have mature cystic teratoma (dermoid cyst) after histopathological evaluation.

Arm Title

Serous or mucinous cystadenoma

Arm Type

Active Comparator

Arm Description

Participants who will have serous or mucinous cystadenoma after histopathological evaluation.

Intervention Type

Procedure

Intervention Name(s)

Laparoscopic cystectomy

Intervention Description

All surgeries will be performed under general anesthesia by laparoscopically.

Primary Outcome Measure Information:

Title

Change in AMH Level

Description

AMH levels of the participants will be investigated before the surgery and 6 months after the surgery.

Time Frame

6 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sabahattin Anil Ari, MD

Organizational Affiliation

Ege University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Ege University Hospital

City

İzmir

ZIP/Postal Code

35100

Country

Turkey

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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