NCT04275674

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
57

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2017

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

October 28, 2019

Completed
4 months until next milestone

First Posted

Study publicly available on registry

February 19, 2020

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
Last Updated

October 4, 2022

Status Verified

September 1, 2022

Enrollment Period

5.9 years

First QC Date

October 28, 2019

Last Update Submit

October 3, 2022

Conditions

ObesityInflammation

Outcome Measures

Primary Outcomes (1)

  • Validity of inflammatory markers

    Use the levels of hsCRP and CA125 provides the information about inflammation.

    1 Day

Eligibility Criteria

Age20 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability 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

You may qualify if:

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

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cheng-Kung University Hospital

Tainan, 70428, Taiwan

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Conditions

ObesityInflammation

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsPathologic Processes

Study Officials

  • Pao-Lin Kuo, MD

    Department of Obstetrics and Gynecology, National Cheng Kung University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Pao-Lin Kuo, MD

CONTACT

886-6-2353535paolink@mail.ncku.edu.tw

PL Kuo, MD

CONTACT

886-6-2353535paolink@mail.ncku.edu.tw

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 28, 2019

First Posted

February 19, 2020

Study Start

August 1, 2017

Primary Completion

July 1, 2023

Study Completion

July 1, 2023

Last Updated

October 4, 2022

Record last verified: 2022-09

Locations

TW(1)