Endometrial Markers in Autoimmune Diseases

NCT03843034 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 22

Last updated 2023-11-02

No results posted yet for this study

Summary

Autoimmune diseases cause a decreased endometrial receptivity during the implantation window, most likely changing the endometrial cytokines pattern due to dysregulation of the inflammatory processes.Therefore, endometrial cytokine profiles will be compared in women with autoimmune disease and normal, fertile women.

The collected endometrial tissue and blood samples will be examined for the cytokines profiling using commercially available ELISA kits.

The sample size was calculated choosing, as primary outcome, changes in endometrial LIF concentration between the disease and control Group, which is our main goal. Given a type I error of 5%, a maximum of 21 women are needed for each Group to reach the desired power of 80% to detect the least changes in concentrations.

Conditions

Interventions

GENETIC

Measure endometrial markers

Endometrial biopsies will be taken from participants in both groups

Sponsors & Collaborators

  • Odense University Hospital

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-18
Primary Completion
2023-01-31
Completion
2023-12-31

Countries

  • Denmark

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03843034 on ClinicalTrials.gov