An observational study in Endometrial Receptivity, Fertility and Autoimmune Diseases, sponsored by Odense University Hospital. Active, not recruiting at 1 site in Denmark. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2023-11-02.
Sponsored by Odense University Hospital · Observational
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.
655 studies on the registry are indexed under Autoimmune Diseases; 275 are open to participants now.
This study's enrollment of 22 is below the median of 300 across 208 observational studies indexed under Autoimmune Diseases.
Browse Autoimmune Diseases studies →Odense University Hospital is the lead sponsor of 468 studies on the registry; 109 are open to participants now.
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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).
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:
Infertile women with autoimmune disease
Genetic: Measure endometrial markers
Women from couples with severe male infertility
Genetic: Measure endometrial markers
Endometrial biopsies will be taken from participants in both groups
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
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.
Time frame: February 18, 2019 - August 2020
Plan to share: No
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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Odense University Hospital