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NCT04275674 Clinical Trial

Inflammasome Activation and Cortisol Metabolism in Obese Women With Recurrent Miscarriage

Obesity Clinical Trial

Official title:
Dr. Pao-Lin Kuo (Department of Obstetrics and Gynecology

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04275674
Other study ID # A-ER-105-481
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date August 1, 2017
Est. completion date July 2023

Study information
Verified date September 2022
Source National Cheng-Kung University Hospital
Contact Pao-Lin Kuo, MD
Phone 886-6-2353535
Email paolink@mail.ncku.edu.tw
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The prevalence of obesity among women of reproductive age is increasing. Obesity represents a chronic low-grade inflammatory state and NLRP3 inflammasome plays a pivotal role in obesity-induced inflammation. Obesity is associated with an increased risk of recurrent miscarriage (RM), but the underlying mechanisms are unclear. Abnormal inflammasome activation was also identified in the endometrium of women who experienced RM. Given inflammasome activation has emerged as common pathophysiology in obesity-related disorder and RM, the investigators wonder whether inflammasome activation occurs in the uterine macrophages of obese women, and result in early reproductive failure.

Description:

pending

Recruitment information / eligibility
Status Recruiting
Enrollment 57
Est. completion date July 2023
Est. primary completion date July 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 20 Years to 50 Years
Eligibility Inclusion Criteria: All women have conceived naturally without the aid of assisted reproductive technologies Exclusion Criteria: N/A

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Taiwan National Cheng-Kung University Hospital Tainan

Sponsors (1)
Lead Sponsor Collaborator
National Cheng-Kung University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Validity of inflammatory markers Use the levels of hsCRP and CA125 provides the information about inflammation. 1 Day
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