NCT05054946

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 19, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 23, 2021

Completed
8 days until next milestone

Study Start

First participant enrolled

October 1, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

September 7, 2022

Status Verified

September 1, 2022

Enrollment Period

11 months

First QC Date

September 19, 2021

Last Update Submit

September 3, 2022

Conditions

Ovarian Cysts

Keywords

ovarian reserveanti-mullerian hormoneovarian cyst

Outcome Measures

Primary Outcomes (1)

  • Change in AMH Level

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

    6 months

Study Arms (3)

Endometrioma

ACTIVE COMPARATOR

Participants who will have endometrioma after histopathological evaluation.

Procedure: Laparoscopic cystectomy

Mature cystic teratoma (dermoid cyst)

ACTIVE COMPARATOR

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

Procedure: Laparoscopic cystectomy

Serous or mucinous cystadenoma

ACTIVE COMPARATOR

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

Procedure: Laparoscopic cystectomy

Interventions

Laparoscopic cystectomyPROCEDURE

All surgeries will be performed under general anesthesia by laparoscopically.

EndometriomaMature cystic teratoma (dermoid cyst)Serous or mucinous cystadenoma

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • no ovarian surgery before

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ege University Hospital

Izmir, 35100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Ovarian Cysts

Condition Hierarchy (Ancestors)

CystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Study Officials

  • Sabahattin Anil Ari, MD

    Ege University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 19, 2021

First Posted

September 23, 2021

Study Start

October 1, 2021

Primary Completion

September 1, 2022

Study Completion

September 1, 2022

Last Updated

September 7, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)