Autoimmune Diseases, Endometrial Receptivity, Fertility
Conditions
Brief 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.
Interventions
GENETICMeasure endometrial markers
Endometrial biopsies will be taken from participants in both groups
Sponsors
Odense University Hospital
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Endometrial cytokine LIF concentration (pg/ml) | February 18, 2019 - August 31, 2020 | The endometrial cytokine LIF profile in endometrial biopsies of women with autoimmune disease will be determined and compared to normal, fertile women (pg/mL) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood concentration of cytokines such as LIF, IL6, TNFα TGFα (pg/ml) | February 18, 2019 - August 2020 | 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. |
| endometrial concentration of cytokines such as, IL6, TNFα TGFα (pg/ml) | February 18, 2019 - August 2020 | 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. |
Countries
Denmark
Outcome results
None listed