Endometrial Markers in Autoimmune Diseases
NCT03843034 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 22
Last updated 2023-11-02
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
- 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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