NCT03843034

Endometrial Markers in Autoimmune Diseases

Endometrial Markers in Women With Autoimmune Diseases Receiving Assisted Reproduction

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 22 (actual)
• Sponsor: Odense University Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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

• Endometrial Receptivity
• Fertility
• Autoimmune Diseases

Interventions

Type	Name	Description
GENETIC	Measure endometrial markers	Endometrial biopsies will be taken from participants in both groups

Timeline

• Start date: 2019-02-18
• Primary completion: 2023-01-31
• Completion: 2023-12-31
• First posted: 2019-02-15
• Last updated: 2023-11-02

Locations

1 site across 1 country: Denmark