IVFVARITI-5NCT01826500
VARITI-5 : Study of Variations of Serum ITIH5 in Women During the Genital Life and in Pathological Situations
An observational study of IVF and Endometriosis, run by Rennes University Hospital at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- IVF, Endometriosis
- What is being tested?
- blood test
- How many people
- 163 participants
- Where
- 2 sitesFrance
- Study dates
- Jan 2013to Jan 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: * Patients with embryo transfer fresh or frozen * Patients from an IVF cycle, * Patients supported surgically for endometriosis or * donors
Who may be able to join
- 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
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- Aged between 18 and 45 years,
- Subjects affiliated to the social security
- Having given free and informed consent in writing.
Who cannot join
- 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.
Show all 22Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
France2 sites
EFS de Bretagne
Rennes, Britanny, 35000
Rennes University Hospital - Hôpital Sud
Rennes, Britanny, 35000
About this study
Official title: 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.
Read the detailed description
Pilot study, prospective, single-center, biomedical
- Conditions
- IVF, Endometriosis
- Being tested
- blood test
- Keywords
- embryo transfer, IVF cycle, endometriosis
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood testOther
blood test
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: blood test | |
| Controls | Controls Receives: Other: blood test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum levels of the protein ITIH5
To establish the normal serum levels of the protein ITIH5 during the life female genital
Measured: Day 1
Secondary outcomes (1)
Serum levels of the protein ITIH5 of healthy volunteers.
Serum levels of the protein ITIH5 of healthy volunteers.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2013 (estimated)
- Study startJan 2013
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IVFStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 163 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karine Morcel, MD, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01826500
- Sponsor's protocol ID
- LOC/12-16 - VARITI-5
- Other IDs
- 2012-A01470-43, 121347B-22, 12/45-878
- Acronym
- VARITI-5
- Status last verified
- Jan 2017
- First submitted
- 25 Mar 2013
- Last updated
- 18 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VARITI-5 : Study of Variations of Serum ITIH5 in Women During the Genital Life and in Pathological Situations.
- ClinicalTrials.gov ID
- NCT01826500
- Acronym / sponsor ID
- VARITI-5 / LOC/12-16 - VARITI-5
- Conditions
- IVF, Endometriosis
- Keywords
- embryo transfer, IVF cycle, endometriosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 163 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 8 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Other: blood testPatients having any of the following criteria: * Patients with embryo transfer fresh or frozen * Patients from an IVF cycle, * Patients supported surgically for endometriosis |
| Controls | – | Other: blood testControls |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- * Patients with embryo transfer fresh or frozen * Patients from an IVF cycle, * Patients supported surgically for endometriosis or * donors
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (22 listed)
- For 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood testblood test | Other | Controls, Patients |
Primary outcome
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
1 secondary outcome
Serum levels of the protein ITIH5 of healthy volunteers.
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karine Morcel, MD principal investigator
Rennes University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of IVF and Endometriosis, run by Rennes University Hospital at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum levels of the protein ITIH5 (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2017.