Endometrial Markers in Autoimmune Diseases

Odense University Hospital22 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

Conditions

Endometrial Receptivity Fertility Autoimmune Diseases

Interventions

Measure endometrial markers

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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)

Time frame: February 18, 2019 - August 31, 2020

Secondary Outcomes

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.

Time frame: 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.