PTEN-AKT-FOXO3 Gene Expression Relation With Low-ovarian Reserve in Endometriomas

August 14, 2019 updated by: GÜRKAN UNCU,PROF. MD, Uludag University

RELATIONSHIP OF LOW-OVER RESERVE WITH PTEN-AKT-FOXO3 GENE EXPRESSION IN THE PRESENCE OF ENDOMETRIOMAS

In this study, we aimed to investigate the relationship between PTEN-AKT-FOXO3 gene expression and decrease in ovarian reserve in the presence of endometrioma and other benign ovarian pathologies.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

It is known that the presence of endometrioma negatively affects ovarian reserve. The development of endometriosis and the effect of the presence of endometrioma on ovarian reserve due to decreased PTEN expression are considered. This study was designed to compare ovarian PTEN-AKT-FOXO3 gene expression and ovarian reserve in patients with underwent surgery caused by endometrioma and those who had ovarian pathology due to other benign causes and PTEN-AKT-FOXO3 gene expression level will be evaluated by RT-PCR analysis.

Study Type

Observational

Enrollment (Anticipated)

60

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
    • Nilufer
      • Bursa, Nilufer, Turkey, 16059
        • Recruiting
        • Uludag University Hospital, Department of Obstetrics and Gynecology
        • Contact:
        • Contact:

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

14 years to 36 years (Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

The study population is the patients examined for ovarian endometriomas and other benign ovarian pathologies

Description

Inclusion Criteria:

  • 1) To be in the range of 18-40 years 2) Patients with an operation indication with >=5 cm endometrioma 3) Patients with operation plan due to non-endometrioma ovarian pathologies

Exclusion Criteria:

  • 1)Patients over the age of 40 2)Patients with suspected malignancy 3)Follow-up patients without indications for operation

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

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
PATİENCE GROUP
  1. To be in the range of 18-40 years

  2. Patients with an operation indication with >=5 cm endometrioma

    1. Symptomatic patients due to endometrioma (dysmenorrhea, dyspareunia, chronic pelvic pain, etc.)
    2. Patients who will be followed for IVF cycle due to infertility
Genetic: PTEN-AKT-FOXO3 Gene Expression
In the patient and patient control groups, 0.5 mm tissue strip will be removed for pathology from the cyst wall removed during surgery. and tissue samples will be stored in phosphate buffered saline at -80 C and PTEN-AKT-FOXO3 gene expression level will be evaluated by RT-PCR analysis.
PATİENCE-CONTROL GROUP
  1. To be in the range of 18-40 years

  2. Patients with operation plan due to non-endometrioma ovarian pathologies

    1. Symptomatic patients with benign ovarian pathology (such as chronic pelvic pain, compression, syphilomas, dysmenorrhea, dyspareunia, etc.)
    2. Asymptomatic, despite a 6-month follow-up period, increase in cyst size or become symptomatic
Genetic: PTEN-AKT-FOXO3 Gene Expression
In the patient and patient control groups, 0.5 mm tissue strip will be removed for pathology from the cyst wall removed during surgery. and tissue samples will be stored in phosphate buffered saline at -80 C and PTEN-AKT-FOXO3 gene expression level will be evaluated by RT-PCR analysis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PTEN AKT FOXO3 gene expression
Time Frame: 30 minutes
In the patient and patient control groups, 0.5 mm tissue strip will be removed for pathology from the cyst wall removed during surgery. and tissue samples will be stored in phosphate buffered saline at -80 C and PTEN-AKT-FOXO3 gene expression level will be evaluated by RT-PCR analysis.
30 minutes

Collaborators and Investigators

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

Sponsor

Uludag University

Investigators

  • Study Director: GURKAN UNCU, Prof, ULUDAG UNIVERSITY HOSPITAL BURSA TURKEY

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

May 27, 2019

Primary Completion (Anticipated)

May 27, 2020

Study Completion (Anticipated)

June 30, 2020

Study Registration Dates

First Submitted

August 14, 2019

First Submitted That Met QC Criteria

August 14, 2019

First Posted (Actual)

August 16, 2019

Study Record Updates

Last Update Posted (Actual)

August 16, 2019

Last Update Submitted That Met QC Criteria

August 14, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UU-MREC-2019-5/28

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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