Skip to content

VARITI-5 : Study of Variations of Serum ITIH5 in Women During the Genital Life and in Pathological Situations

VARITI-5 : Study of Variations of Serum ITIH5 in Women During the Genital Life and in Pathological Situations.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01826500
Acronym
VARITI-5
Enrollment
163
Registered
2013-04-08
Start date
2013-01-31
Completion date
2017-01-31
Last updated
2017-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endometriosis, IVF

Keywords

embryo transfer, IVF cycle, endometriosis

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.

Detailed description

Pilot study, prospective, single-center, biomedical

Interventions

OTHERblood test

blood test

Sponsors

Rennes University Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

For patients * Patients having any of the following criteria: * Patients with embryo transfer fresh or frozen * Patients from an IVF cycle, * Patients supported surgically for endometriosis Age between 18 and 45 years, Subjects affiliated to the social security Having given free and informed consent in writing. For donors * Aged between 18 and 45 years, * Subjects affiliated to the social security * Having given free and informed consent in writing.

Exclusion criteria

For patients For all patients: * Subjects under 18 years (minors) * The majors protected (judicial protection, guardianship and curatorship) and persons deprived of their liberty, * Patients with cancer of gynaecological origin or not, * Patients with acute or chronic liver disease. For patients with embryo transfer: \- Patients with endometriosis. For patients with endometriosis: \- Hormonal treatment for endometriosis in progress. For donors For all donors: * Subjects under 18 years (minors) * The majors protected (judicial protection, guardianship and curatorship) and persons deprived of their liberty, * Patients with cancer of gynaecological origin or not, * Patients with acute or chronic liver disease. For female subjects: * Taking hormonal contraception whatever the pharmaceutical or any other œstro-progestative treatment, * Past or present support in Medically Assisted Reproduction, * Subjects with an ongoing pregnancy, * Subjects with endometriosis * Menopausal subjects.

Design outcomes

Primary

MeasureTime frameDescription
Serum levels of the protein ITIH5Day 1To establish the normal serum levels of the protein ITIH5 during the life female genital

Secondary

MeasureTime frameDescription
Serum levels of the protein ITIH5 of healthy volunteers.Day 1Serum levels of the protein ITIH5 of healthy volunteers.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026