Endometrial Markers in Autoimmune Diseases

Study Overview
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Brief Summary
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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.

Official Title
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Endometrial Markers in Women With Autoimmune Diseases Receiving Assisted Reproduction

Conditions
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Endometrial Receptivity, Fertility, Autoimmune Diseases

Intervention / Treatment
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* Genetic: Measure endometrial markers


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Study group<br>Infertile women with autoimmune disease | Genetic: Measure endometrial markers<br>* Endometrial biopsies will be taken from participants in both groups<br>|
| Control group<br>Women from couples with severe male infertility | Genetic: Measure endometrial markers<br>* Endometrial biopsies will be taken from participants in both groups<br>|

What is the study measuring?
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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 |