Ignite Creation Date:
2024-05-06 @ 12:46 PM
Last Modification Date:
2024-10-26 @ 1:03 PM
Study NCT ID:
NCT03843034
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-11-02
First Post:
2019-02-11
Brief Title:
Endometrial Markers in Autoimmune Diseases
Sponsor:
Odense University Hospital
Organization:
Odense University Hospital
Study Overview
Official Title:
Endometrial Markers in Women With Autoimmune Diseases Receiving Assisted Reproduction
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 processesTherefore 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
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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None