Endometrial Markers in Autoimmune Diseases

Active, not recruiting

• Conditions: Endometrial Receptivity; Fertility; Autoimmune Diseases
• Interventions: Genetic: Measure endometrial markers

• Registration Number: NCT03843034
• Lead Sponsor: Odense University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-02-11
• Study First Submitted QC: 2019-02-14
• Study First Posted: 2019-02-15
• Study Start: 2019-02-18
• Primary Completion: 2023-01-31
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-01
• Last Update Posted: 2023-11-02
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 22

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.

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control group	Measure endometrial markers	Women from couples with severe male infertility
Study group	Measure endometrial markers	Infertile women with autoimmune disease

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Centre of Andrology & Fertility Clinic, Department D, Odense University Hospital; 🇩🇰 Odense, Denmark