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

Sponsor
Uludag University (Other)
Overall Status
Unknown status
CT.gov ID
NCT04058912
Collaborator
(none)
60
2
13.1
30
2.3

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Genetic: PTEN-AKT-FOXO3 Gene Expression

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 Design

Study Type:
Observational
Anticipated Enrollment :
60 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
RELATIONSHIP OF LOW-OVER RESERVE WITH PTEN-AKT-FOXO3 GENE EXPRESSION IN THE PRESENCE OF ENDOMETRIOMAS
Actual Study Start Date :
May 27, 2019
Anticipated Primary Completion Date :
May 27, 2020
Anticipated Study Completion Date :
Jun 30, 2020

Arms and Interventions

Arm Intervention/Treatment
PATİENCE GROUP

To be in the range of 18-40 years Patients with an operation indication with >=5 cm endometrioma Symptomatic patients due to endometrioma (dysmenorrhea, dyspareunia, chronic pelvic pain, etc.) 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

To be in the range of 18-40 years Patients with operation plan due to non-endometrioma ovarian pathologies Symptomatic patients with benign ovarian pathology (such as chronic pelvic pain, compression, syphilomas, dysmenorrhea, dyspareunia, etc.) 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.

Outcome Measures

Primary Outcome Measures

  1. PTEN AKT FOXO3 gene expression [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 40 Years
Sexes Eligible for Study:
Female
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Uludag University Hospital, Department of Obstetrics and Gynecology Bursa Nilufer Turkey 16059
2 Uludag University Hospital, Department of Obstetrics and Gynecology Bursa Nilufer Turkey 16059

Sponsors and Collaborators

  • Uludag University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
GÜRKAN UNCU,PROF. MD, : Principal Investigator. Professor, Obstetrician and Gynecologist, Uludag University
ClinicalTrials.gov Identifier:
NCT04058912
Other Study ID Numbers:
  • UU-MREC-2019-5/28
First Posted:
Aug 16, 2019
Last Update Posted:
Aug 16, 2019
Last Verified:
Aug 1, 2019
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 16, 2019