Relationship Between Endoplasmic Reticulum Stress and Pain in Patients With Endometriosis

• Sponsor: Kanuni Sultan Suleyman Training and Research Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT04440397
• Collaborator: (none)
• Enrollment: 86
• Location: 1
• Actual Duration (Months): 4.6
• Patients Per Site Per Month: 18.7

Study Details

Study Description

Brief Summary

The correlation between painful symptoms (dysmenorrhea, dysparonia, dysuria, chronic pelvic pain) symptoms and endoplasmic reticulum stress was investigated in 86 patients diagnosed with endometriosis. For this, xbp-1 (x box binding protein-1) level was measured in patients. XBP-1 is an endoplasmic reticulum stress indicator and is known to be involved in pain pathogenesis.

Condition or Disease	Intervention/Treatment	Phase
Endometriosis; Endoplasmic Reticulum Stress; Endometriosis-related Pain	Other: xbp-1 - endometriosis patients group

Detailed Description

Women between the ages of 18-50 who were diagnosed with endometriosis by surgery and ultrasound, without known rheumatological or metabolic diseases were included in the study. Most of the patients are composed of newly diagnosed patients.

Study Design

• Study Type: Observational
• Actual Enrollment: 86 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Endoplasmic Reticulum Stress and Endometriosis Releated Pain
• Actual Study Start Date: Mar 17, 2020
• Actual Primary Completion Date: Aug 1, 2020
• Actual Study Completion Date: Aug 4, 2020

Outcome Measures

Primary Outcome Measures

1. Evaluation of the correlations between the results of XBP-1 levels and the stages and pain symptoms of endometriosis. [5 months]

Secondary Outcome Measures

1. serum XBP-1levels in patients wit endometriosis [5 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• diagnosed endometriosis with ultrasound or surgery

• no metabolic diseases

• no rheumatological diseases

Exclusion Criteria:

• Immune modulator, hormonal, anti-inflammatory use history in the last 3 months

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pinar Yalcin Bahat	Istanbul	İ̇stanbul	Turkey	34000

Sponsors and Collaborators

• Kanuni Sultan Suleyman Training and Research Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Pınar Yalcin bahat, Principal Investigator, Kanuni Sultan Suleyman Training and Research Hospital
• ClinicalTrials.gov Identifier: NCT04440397
• Other Study ID Numbers: xbpendo
• First Posted: Jun 19, 2020
• Last Update Posted: Aug 7, 2020
• Last Verified: Aug 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Endometriosis

Study Results

No Results Posted as of Aug 7, 2020