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Endometrial Markers in Autoimmune Diseases

Sponsor
Odense University Hospital (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03843034
Collaborator
(none)
22
Enrollment
1
Location
50.3
Anticipated Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Genetic: Measure endometrial markers

Study Design

Study Type:
Observational
Actual Enrollment :
22 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Endometrial Markers in Women With Autoimmune Diseases Receiving Assisted Reproduction
Actual Study Start Date :
Feb 18, 2019
Actual Primary Completion Date :
Jan 31, 2022
Anticipated Study Completion Date :
Apr 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Study group

Infertile women with autoimmune disease

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

Women from couples with severe male infertility

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

Outcome Measures

Primary Outcome Measures

  1. 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 Outcome Measures

  1. 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.

  2. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
Female
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Centre of Andrology & Fertility Clinic, Department D, Odense University Hospital Odense Denmark DK-5000

Sponsors and Collaborators

  • Odense University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jens Fedder, Professor, MD, PhD, Odense University Hospital
ClinicalTrials.gov Identifier:
NCT03843034
Other Study ID Numbers:
  • Lab.Reprod.Biol. - Odense.04
First Posted:
Feb 15, 2019
Last Update Posted:
May 26, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Autoimmune Diseases

Study Results

No Results Posted as of May 26, 2022