Endometrial Markers in Autoimmune Diseases

NCT03843034 | Unknown DMC

• 1 other identifier: Lab.Reprod.Biol. - Odense.04
• Study Type: observational
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Endometrial Receptivity; Fertility; Autoimmune Diseases

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Blood concentration of cytokines such as LIF, IL6, TNFα TGFα (pg/ml)

  February 18, 2019 - August 2020

• endometrial concentration of cytokines such as, IL6, TNFα TGFα (pg/ml)

  February 18, 2019 - August 2020

Study Arms (2)

Study group

Infertile women with autoimmune disease

Genetic: Measure endometrial markers

Control group

Women from couples with severe male infertility

Genetic: Measure endometrial markers

Interventions

Measure endometrial markers GENETIC

Endometrial biopsies will be taken from participants in both groups

Control group; Study group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: It is a study on endometrial factors in female infertility
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

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).

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Odense University Hospital: lead

Study Sites (1)

Centre of Andrology & Fertility Clinic, Department D, Odense University Hospital

Odense, DK-5000, Denmark

Location

Biospecimen

Retention: SAMPLES WITH DNA

Endometrial biopsies

MeSH Terms

Conditions

Autoimmune Diseases

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, MD, PhD

Study Record Dates

• First Submitted: February 11, 2019
• First Posted: February 15, 2019
• Study Start: February 18, 2019
• Primary Completion: January 31, 2023
• Study Completion: December 31, 2023
• Last Updated: November 2, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)