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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study group | Infertile women with autoimmune disease |
| |
| Control group | Women from couples with severe male infertility |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Measure endometrial markers | Genetic | Endometrial biopsies will be taken from participants in both groups |
|
| 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 |
| 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) |
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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:
It is a study on endometrial factors in female infertility
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).
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre of Andrology & Fertility Clinic, Department D, Odense University Hospital | Odense | DK-5000 | Denmark |
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| ID | Term |
|---|---|
| D001327 | Autoimmune Diseases |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
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Endometrial biopsies
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 |