Inflammasome Activation and Cortisol Metabolism in Obese Women With Recurrent Miscarriage

October 3, 2022 updated by: National Cheng-Kung University Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Detailed Description

pending

Study Type

Observational

Enrollment (Anticipated)

57

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Taiwan
      • Tainan, Taiwan, 70428
        • Recruiting
        • National Cheng-Kung University Hospital
        • Contact:
        • Principal Investigator:
          • Pao-Lin Kuo, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Cases were referred for 200 women who have experienced at least two consecutive miscarriages are recruited from outpatient clinics of our hospital, including at least 50 obese women

Description

Inclusion Criteria:

All women have conceived naturally without the aid of assisted reproductive technologies

Exclusion Criteria:

N/A

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Validity of inflammatory markers
Time Frame: 1 Day
Use the levels of hsCRP and CA125 provides the information about inflammation.
1 Day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cheng-Kung University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2017

Primary Completion (Anticipated)

July 1, 2023

Study Completion (Anticipated)

July 1, 2023

Study Registration Dates

First Submitted

October 28, 2019

First Submitted That Met QC Criteria

February 17, 2020

First Posted (Actual)

February 19, 2020

Study Record Updates

Last Update Posted (Actual)

October 4, 2022

Last Update Submitted That Met QC Criteria

October 3, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A-ER-105-481

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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