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

NCT ID: NCT04058912

Last Updated: 2019-08-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-05-27

Study Completion Date

2020-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Ovarian Reserve, Endometrioma, PTEN-AKT-FOXO3 Gene Expression

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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

PTEN-AKT-FOXO3 Gene Expression

Intervention Type GENETIC

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

PTEN-AKT-FOXO3 Gene Expression

Intervention Type GENETIC

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.

Interventions

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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.

Intervention Type GENETIC

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Uludag University

OTHER

Sponsor Role lead

Responsible Party

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GÜRKAN UNCU,PROF. MD

: Principal Investigator. Professor, Obstetrician and Gynecologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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GURKAN UNCU, Prof

Role: STUDY_DIRECTOR

ULUDAG UNIVERSITY HOSPITAL BURSA TURKEY

Locations

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Uludag University Hospital, Department of Obstetrics and Gynecology

Bursa, Nilufer, Turkey (Türkiye)

Site Status RECRUITING

Uludag University Hospital, Department of Obstetrics and Gynecology

Bursa, Nilufer, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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HAMZA F SEN, MD

Role: CONTACT

+90 544 3939159

Isil Kasapoglu, MD

Role: CONTACT

+905305455848

Facility Contacts

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HAMZA F SEN, MD

Role: primary

+90 5443939159

Isil Kasapoglu, MD

Role: backup

+905305455848

H.FURKAN MD SEN

Role: primary

+90 5443939159

Isil MD Kasapoglu

Role: backup

+905305455848

References

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Govatati S, Kodati VL, Deenadayal M, Chakravarty B, Shivaji S, Bhanoori M. Mutations in the PTEN tumor gene and risk of endometriosis: a case-control study. Hum Reprod. 2014 Feb;29(2):324-36. doi: 10.1093/humrep/det387. Epub 2013 Oct 23.

Reference Type BACKGROUND
PMID: 24154570 (View on PubMed)

Kasapoglu I, Ata B, Uyaniklar O, Seyhan A, Orhan A, Yildiz Oguz S, Uncu G. Endometrioma-related reduction in ovarian reserve (ERROR): a prospective longitudinal study. Fertil Steril. 2018 Jul 1;110(1):122-127. doi: 10.1016/j.fertnstert.2018.03.015. Epub 2018 Jun 20.

Reference Type BACKGROUND
PMID: 29935810 (View on PubMed)

Other Identifiers

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UU-MREC-2019-5/28

Identifier Type: -

Identifier Source: org_study_id

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