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

NCT01826500 | Completed

• 4 other identifiers: LOC/12-16 - VARITI-52012-A01470-43121347B-2212/45-878
• Study Type: observational
• Target: 163
• Locations: 1 country
• Sites: 2

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.

Conditions

IVF; Endometriosis

Keywords

embryo transfer; IVF cycle; endometriosis

Outcome Measures

Primary Outcomes (1)

• Serum levels of the protein ITIH5

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

  Day 1

Secondary Outcomes (1)

• Serum levels of the protein ITIH5 of healthy volunteers.

  Day 1

Study Arms (2)

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

Other: blood test

Controls

Controls

Other: blood test

Interventions

blood test OTHER

blood test

Controls; Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

* Patients with embryo transfer fresh or frozen * Patients from an IVF cycle, * Patients supported surgically for endometriosis or * donors

You may qualify if:

• 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.

You may not qualify if:

• 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,

Sponsors & Collaborators

• Rennes University Hospital: lead

Study Sites (2)

EFS de Bretagne

Rennes, Britanny, 35000, France

Location

Rennes University Hospital - Hôpital Sud

Rennes, Britanny, 35000, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum

MeSH Terms

Conditions

Endometriosis

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Karine Morcel, MD

  Rennes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2013
• First Posted: April 8, 2013
• Study Start: January 1, 2013
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: January 18, 2017

Record last verified: 2017-01

Locations

FR (2)