Ignite Creation Date:
2024-05-06 @ 6:23 PM
Last Modification Date:
2024-10-26 @ 2:47 PM
Study NCT ID:
NCT05648136
Status:
RECRUITING
Last Update Posted:
2022-12-13
First Post:
2022-12-05
Brief Title:
Immune Profile Analysis and Biomarker Identification in Women With Repeated Implantation Failure or Unexplained Recurrent Spontaneous Miscarriage
Sponsor:
Centre Hospitalier Universitaire Amiens
Organization:
Centre Hospitalier Universitaire Amiens
Study Overview
Official Title:
Immune Profile Analysis and Biomarker Identification in Women With Repeated Implantation Failure or Unexplained Recurrent Spontaneous Miscarriage
Status:
RECRUITING
Status Verified Date:
2022-12
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:
ERIM
Brief Summary:
Implantation is a determining step in human reproduction which requires the transition from a pro-inflammatory state to an anti-inflammatory state allowing the implantation of a competent embryo within a receptive endometrium and then the maternal immunotolerance towards the alloantigenic fetus Repeat implantation failures RIFs that refers to the fail to achieve a clinical pregnancy after the transfer of at least 3-4 good quality embryos or two blastocysts and unexplained recurrent spontaneous miscarriage RM 2-3 could be related in some patients to immune imbalances characterized by an excessive and prolonged inflammatory response andor a defect of anti-inflammatory regulation In this context several therapies have been evaluated in patients with RIFs or RMs in order to restore the immune balance with heterogeneous results No serum biomarker assay has been routinely approved to identify patients with immune imbalances that may explain repeated pregnancy failures and to predict the success of the subsequent IVFICSI cycle The immunological analysis on peripheral blood will be based on the determination of the proportions of immune subpopulations eg CD4 et CD8 TH1 TH2 TH17 Treg ILC 1 ILC2 and ILC3 on the one hand and the circulating level of plasma cytokines on the other hand
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