Endometrial Markers in Autoimmune Diseases

Odense University Hospital

Status: Active, not recruiting

Conditions: Endometrial Receptivity; Fertility; Autoimmune Diseases

Treatments: Genetic: Measure endometrial markers

Study type: Observational

Funder types: Other

Identifiers

NCT03843034

Lab.Reprod.Biol. - Odense.04

Details and patient eligibility

About

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.

Enrollment: 22 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

22 participants in 2 patient groups

Study group

Description:

Infertile women with autoimmune disease

Treatment:

Genetic: Measure endometrial markers

Control group

Description:

Women from couples with severe male infertility

Treatment:

Genetic: Measure endometrial markers