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

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

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04058912
• Other study ID #: UU-MREC-2019-5/28
• Status: Recruiting
• Start date: May 27, 2019
• Est. completion date: June 30, 2020

Study information

• Verified date: August 2019
• Source: Uludag University
• Contact: HAMZA F SEN, MD
• Phone: +90 544 3939159
• Email: hamzafurkansen[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 30, 2020
• Est. primary completion date: May 27, 2020
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
Turkey	Uludag University Hospital, Department of Obstetrics and Gynecology	Bursa	Nilufer
Turkey	Uludag University Hospital, Department of Obstetrics and Gynecology	Bursa	Nilufer

Sponsors (1)

Lead Sponsor	Collaborator
Uludag University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	30 minutes