Endometrial Markers in Autoimmune Diseases

Endometrial Markers in Women With Autoimmune Diseases Receiving Assisted Reproduction

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Autoimmune Diseases; Fertility; Endometrial Receptivity
• Intervention / Treatment: Genetic: Measure endometrial markers

• Study Type: Observational
• Enrollment (Actual): 22

Contacts and Locations

Study Locations

• Denmark
  • Odense, Denmark, DK-5000
    • Centre of Andrology & Fertility Clinic, Department D, Odense University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Women with thyroid diseases, rheumatoid arthritis, inflammatory bowel diseases, multiple sclerosis, diabetes mellitus, and psoriasis will be included in the study Group (Age: 20-40 years old). Healthy women receiving assisted reproduction due to male infertility will be included in the control Group (Age: 20-40 years old).

Description

Inclusion Criteria:

Study group:

* Females with infertility combined with autoimmune disease and in fertility treatment.

Control group:

* Female from couples with severe male infertility and in fertility treatment.

Exclusion Criteria:

• Language problems to such an extent that the subjects do not understand the scope of the study.
• Abnormal follicle stimulating hormone (FSH),
• Abnormal antral follicles Count
• Genital infections
• Endometriosis
• Tubal occlusion
• Polycystic ovarian syndrome

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Study group; Infertile women with autoimmune disease	Genetic: Measure endometrial markers; Endometrial biopsies will be taken from participants in both groups
Control group; Women from couples with severe male infertility	Genetic: Measure endometrial markers; Endometrial biopsies will be taken from participants in both groups

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Endometrial cytokine LIF concentration (pg/ml)	The endometrial cytokine LIF profile in endometrial biopsies of women with autoimmune disease will be determined and compared to normal, fertile women (pg/mL)	February 18, 2019 - August 31, 2020

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood concentration of cytokines such as LIF, IL6, TNFα TGFα (pg/ml)	The blood cytokines concentration will be compared between the autoimmune diseases group and the control group. Moreover the cytokines concentration in blood and endometrial tissue will be compared.	February 18, 2019 - August 2020
endometrial concentration of cytokines such as, IL6, TNFα TGFα (pg/ml)	The endometrial cytokines concentration will be compared between the autoimmune diseases group and the control group. Moreover the cytokines concentration in blood and endometrial tissue will be compared.	February 18, 2019 - August 2020

Collaborators and Investigators

• Sponsor: Odense University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 18, 2019
• Primary Completion (Actual): January 31, 2023
• Study Completion (Estimated): December 31, 2023

Study Registration Dates

• First Submitted: February 11, 2019
• First Submitted That Met QC Criteria: February 14, 2019
• First Posted (Actual): February 15, 2019

Study Record Updates

• Last Update Posted (Actual): November 2, 2023
• Last Update Submitted That Met QC Criteria: November 1, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases
• Other Study ID Numbers: Lab.Reprod.Biol. - Odense.04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No