Endometrial Markers in Autoimmune Diseases

Autoimmune Diseases Clinical Trial

Official title:

Endometrial Markers in Women With Autoimmune Diseases Receiving Assisted Reproduction

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03843034
• Other study ID #: Lab.Reprod.Biol. - Odense.04
• Status: Active, not recruiting
• Start date: February 18, 2019
• Est. completion date: December 31, 2023

Study information

• Verified date: November 2023
• Source: Odense University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 22
• Est. completion date: December 31, 2023
• Est. primary completion date: January 31, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Autoimmune Diseases
• Endometrial Receptivity
• Fertility

Intervention

Genetic:
• Measure endometrial markers
Endometrial biopsies will be taken from participants in both groups

Locations

Country	Name	City	State
Denmark	Centre of Andrology & Fertility Clinic, Department D, Odense University Hospital	Odense

Sponsors (1)

Lead Sponsor	Collaborator
Odense University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Blood concentration of cytokines such as LIF, IL6, TNFa TGFa (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
Secondary	endometrial concentration of cytokines such as, IL6, TNFa TGFa (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