Completed

NCT Number: NCT01826500

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

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.

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Key information

Conditions

IVF Endometriosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Urogenital Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

EFS de Bretagne, Rennes, Britanny, France

About this study

Pilot study, prospective, single-center, biomedical

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Blood Test

Other

blood test

Primary outcomes

Serum levels of the protein ITIH5

Time frame: Day 1

To establish the normal serum levels of the protein ITIH5 during the life female genital

Secondary outcomes

Serum levels of the protein ITIH5 of healthy volunteers.

Time frame: Day 1

Serum levels of the protein ITIH5 of healthy volunteers.

Sponsors and collaborators

Lead sponsor

Rennes University Hospital

Other

Registry information

Official study title

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

Acronym: VARITI-5

Important dates

Study start: 2013
Primary completion: 2017
Study completion: 2017
First posted: Apr 8, 2013
Registry last updated: Jan 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed