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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Rennes University Hospital
Sponsor:
Information provided by (Responsible Party):
Rennes University Hospital
ClinicalTrials.gov Identifier:
NCT01826500
First received: March 25, 2013
Last updated: August 5, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention
IVF
Endometriosis
Other: blood test

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: VARITI-5 : Study of Variations of Serum ITIH5 in Women During the Genital Life and in Pathological Situations.

Resource links provided by NLM:


Further study details as provided by Rennes University Hospital:

Primary Outcome Measures:
  • Serum levels of the protein ITIH5 [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    To establish the normal serum levels of the protein ITIH5 during the life female genital


Secondary Outcome Measures:
  • Serum levels of the protein ITIH5 of healthy volunteers. [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Serum levels of the protein ITIH5 of healthy volunteers.


Biospecimen Retention:   Samples Without DNA

serum


Estimated Enrollment: 175
Study Start Date: January 2013
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
blood test
Controls
Controls
Other: blood test
blood test

Detailed Description:

Pilot study, prospective, single-center, biomedical

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01826500

Contacts
Contact: Karine Morcel, MD karine.morcel@chu-rennes.fr
Contact: Daniel Guerrier, PhD danile.guerrie@rennes-univ1.fr

Locations
France
EFS de Bretagne Completed
Rennes, Britanny, France, 35000
Rennes University Hospital - Hôpital Sud Recruiting
Rennes, Britanny, France, 35000
Contact: Karine Morcel, MD         
Principal Investigator: Karine Morcel, MD         
Sponsors and Collaborators
Rennes University Hospital
Investigators
Principal Investigator: Karine Morcel, MD Rennes University Hospital
  More Information

No publications provided

Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT01826500     History of Changes
Other Study ID Numbers: LOC/12-16 - VARITI-5, 2012-A01470-43, 121347B-22, 12/45-878
Study First Received: March 25, 2013
Last Updated: August 5, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by Rennes University Hospital:
embryo transfer
IVF cycle
endometriosis

Additional relevant MeSH terms:
Endometriosis
Genital Diseases, Female

ClinicalTrials.gov processed this record on October 30, 2014