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

• Sponsor: Ege University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05054946
• Collaborator: (none)
• Enrollment: 55
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 11
• Patients Per Site Per Month: 5

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Ovarian Cysts	Procedure: Laparoscopic cystectomy	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 55 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Effect of Laparoscopic Surgery on Ovarian Reserve According to Cyst Types
• Actual Study Start Date: Oct 1, 2021
• Anticipated Primary Completion Date: Sep 1, 2022
• Anticipated Study Completion Date: Sep 1, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Change in AMH Level [6 months]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ege University Hospital	İzmir		Turkey	35100

Sponsors and Collaborators

• Ege University

Investigators

• Principal Investigator: Sabahattin Anil Ari, MD, Ege University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sabahattin Anıl Arı, Principal Investigator, Ege University
• ClinicalTrials.gov Identifier: NCT05054946
• Other Study ID Numbers: 17/056
• First Posted: Sep 23, 2021
• Last Update Posted: Nov 15, 2021
• Last Verified: Nov 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Sabahattin Anıl Arı, Principal Investigator, Ege University: ovarian reserve; anti-mullerian hormone; ovarian cyst
• Additional relevant MeSH terms: Cysts; Ovarian Cysts

Study Results

No Results Posted as of Nov 15, 2021