Ignite Creation Date:
2024-05-06 @ 1:30 AM
Last Modification Date:
2024-10-26 @ 11:05 AM
Study NCT ID:
NCT01826500
Status:
COMPLETED
Last Update Posted:
2017-01-18
First Post:
2013-03-25
Brief Title:
VARITI-5 Study of Variations of Serum ITIH5 in Women During the Genital Life and in Pathological Situations
Sponsor:
Rennes University Hospital
Organization:
Rennes University Hospital
Study Overview
Official Title:
VARITI-5 Study of Variations of Serum ITIH5 in Women During the Genital Life and in Pathological Situations
Status:
COMPLETED
Status Verified Date:
2017-01
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:
VARITI-5
Brief Summary:
The five proteins of the ITI Inter-α-trypsin inhibitor family are essential components of the extracellular matrix the dynamics of which they participate in the processes of cellular differentiation and proliferation I The ITIH1 ITIH2 ITIH3 and ITIH4 genes seem to be overwhelmingly expressed in the liver this organ secreting then the corresponding proteins in the general circulation The only data on ITIH5 indicate that this gene is poorly expressed in the liver and that the major source of its expression is the placenta In the context of genetic studies on the syndrome of Mayer-Rokitansky-Küster-Hauser congenital aplasia of the uterus and vagina the investigators have shown the involvement of ITIH5 and implemented validation experiments of this gene in mice The investigators have shown that the production of ITIH5 by the uterus varies greatly depending on the physiological state of this organ especially during pregnancy and the estrous cycle The investigators also found that most of the production ITIH5 was located in the uterus Therefore the serum dosage of ITIH5 could be used clinically as a new biological marker specific to the uterus This non-invasive biological marker could thus assist in the diagnosis and the understanding of uterine pathologies ITIH5 rate being correlated to endometrial proliferation its dosage could be an early and non-invasive marker of endometriosis The peak of production of ITIH5 by the uterus at the time of embryo implantation window indicates that the assay could provide a better assessment of endometrial receptivity to embryo It then could be a hand tool of diagnosis in some cases of early repeated miscarriages and secondly a prognostic tool for embryo implantation in the context of in vitro fertilization
The investigators conducted an initial feasibility study on the serum dosage of ITIH5 which was approved by the ethics committee of the University Hospital of Rennes This first step has been validated Now the project is to perform a quantitative analysis of ITIH5 and to correlate clinical and biological data of relevant pathological and physiological situations This project was the subject of a national and international patents of which the University Hospital of Rennes is promoter
The investigators conducted an initial feasibility study on the serum dosage of ITIH5 which was approved by the ethics committee of the University Hospital of Rennes This first step has been validated Now the project is to perform a quantitative analysis of ITIH5 and to correlate clinical and biological data of relevant pathological and physiological situations This project was the subject of a national and international patents of which the University Hospital of Rennes is promoter
Detailed Description:
Pilot study prospective single-center biomedical
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1245-878 | OTHER | CPP Rennes Ouest V | None |
| 2012-A01470-43 | OTHER | None | None |
| 121347B-22 | OTHER | None | None |