InfertilityNCT00837642
Vascular Dysfunction in Offspring of Assisted Reproduction Technologies
An observational study of Infertility, run by University of Lausanne Hospitals at 1 site in Switzerland.
Trial summary
The prevalence of infertility has been estimated at 9% worldwide. The steadily increasing use of assisted reproductive technologies (ART) has allowed millions of infertile couples to have children. These children make up for 1 to 4% of the population in developed countries. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Infertility
- What is being tested?
- Transthoracic echocardiography
- How many people
- 100 participants
- Where
- 1 siteSwitzerland
- Study dates
- Oct 2008to Jun 2021
- 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 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: All the partcicipants that have been participated in our previous studies will be asked to take part in this new study.
Who may be able to join
- Offspring of ART
- Healthy
- Born at term
Who cannot join
- Cardio-pulmonary malformations
- Neuro-muscular malformations
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital
Bern, Canton of Bern, 3010
Emrush Rexhaj, PD, +4131 632 21 11, emrush.rexhaj@insel.ch
About this study
The prevalence of infertility has been estimated at 9% worldwide. The steadily increasing use of assisted reproductive technologies (ART) has allowed millions of infertile couples to have children. These children make up for 1 to 4% of the population in developed countries. ART involves the manipulation of early embryos at a time when they may be particularly vulnerable to external disturbances. In line with this concept, studies in mice suggest that ART alters the activity of enzymes involved in the regulation of metabolic and cardiovascular homeostasis. Alternatively, infertility itself or the drugs used to stimulate ovulation may have adverse effects on the outcome of the offspring. The safety of ART for long-term health is, therefore, of utmost importance. Among the potential long-term consequences of ART, cardiovascular disease may represent an important candidate, but there is no information.
Investigators show that, children born after in vitro fertilization (IVF) present systemic and pulmonary vascular dysfunction at high-altitude when compared to age- and sex-matched control subjects. A 5 years follow-up study shows that premature vascular aegieng persist and evolve to arterial hypertension. Arterial hypertension may induce cardiac dysfunction.
Therefore, the major goal of this proposal is to assess cardiac function in apparently healthy participants born after ART.
- Conditions
- Infertility
- Being tested
- Transthoracic echocardiography
- Keywords
- Vascular function in offspring of ART
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transthoracic echocardiographyDiagnostic test
Full transthoracic echocardiography will be performed.
| Study group | Role | What they receive |
|---|---|---|
| ART (Assited reproductive technologies) | In participants born after IVF will be performed a transthoracic echocardiography Receives: Diagnostic Test: Transthoracic echocardiography | |
| Control | In participants naturally conceived will be performed a transthoracic echocardiography Receives: Diagnostic Test: Transthoracic echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac function
Ejection fraction [%]
Measured: 1 year
Secondary outcomes (1)
Left ventricular musce mass
Left ventricular muscle mass [g/m2]
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2009 (estimated)
- Study startOct 2008
- Primary completionDec 2020 (estimated)
- Study completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for InfertilityStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Lausanne Hospitals
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Urs Scherrer, University of Lausanne Hospitals
- Investigators
- Emrush Rexhaj, PD, Principal investigator, University Hospital of Bern, Cardiology, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00837642
- Sponsor's protocol ID
- 35/07
- Status last verified
- Feb 2020
- First submitted
- 4 Feb 2009
- Last updated
- 20 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Meister TA, Rimoldi SF, Soria R, von Arx R, Messerli FH, Sartori C, Scherrer U, Rexhaj E. Association of Assisted Reproductive Technologies With Arterial Hypertension During Adolescence. J Am Coll Cardiol. 2018 Sep 11;72(11):1267-1274. doi: 10.1016/j.jacc.2018.06.060.
PubMed 30190005Scherrer U, Rimoldi SF, Rexhaj E, Stuber T, Duplain H, Garcin S, de Marchi SF, Nicod P, Germond M, Allemann Y, Sartori C. Systemic and pulmonary vascular dysfunction in children conceived by assisted reproductive technologies. Circulation. 2012 Apr 17;125(15):1890-6. doi: 10.1161/CIRCULATIONAHA.111.071183. Epub 2012 Mar 20.
PubMed 22434595
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vascular Dysfunction in Offspring of Assisted Reproduction Technologies
- ClinicalTrials.gov ID
- NCT00837642
- Acronym / sponsor ID
- 35/07
- Conditions
- Infertility
- Keywords
- Vascular function in offspring of ART
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Lausanne HospitalsUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 5 Feb 2009 (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 prevalence of infertility has been estimated at 9% worldwide. The steadily increasing use of assisted reproductive technologies (ART) has allowed millions of infertile couples to have children. These children make up for 1 to 4% of the population in developed countries. ART involves the manipulation of early embryos at a time when they may be particularly vulnerable to external disturbances. In line with this concept, studies in mice suggest that ART alters the activity of enzymes involved in the regulation of metabolic and cardiovascular homeostasis. Alternatively, infertility itself or the drugs used to stimulate ovulation may have adverse effects on the outcome of the offspring. The safety of ART for long-term health is, therefore, of utmost importance. Among the potential long-term consequences of ART, cardiovascular disease may represent an important candidate, but there is no information.
Investigators show that, children born after in vitro fertilization (IVF) present systemic and pulmonary vascular dysfunction at high-altitude when compared to age- and sex-matched control subjects. A 5 years follow-up study shows that premature vascular aegieng persist and evolve to arterial hypertension. Arterial hypertension may induce cardiac dysfunction.
Therefore, the major goal of this proposal is to assess cardiac function in apparently healthy participants born after ART.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ART (Assited reproductive technologies) | – | Diagnostic Test: Transthoracic echocardiographyIn participants born after IVF will be performed a transthoracic echocardiography |
| Control | – | Diagnostic Test: Transthoracic echocardiographyIn participants naturally conceived will be performed a transthoracic echocardiography |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- All the partcicipants that have been participated in our previous studies will be asked to take part in this new study.
Key inclusion criteria (3 listed)
- Offspring of ART
- Healthy
- Born at term
Key exclusion criteria (2 listed)
- Cardio-pulmonary malformations
- Neuro-muscular malformations
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 |
|---|---|---|
| Transthoracic echocardiographyFull transthoracic echocardiography will be performed. | Diagnostic test | ART (Assited reproductive technologies), Control |
Primary outcome
Cardiac function
Time frame: 1 year
Ejection fraction [%]
1 secondary outcome
Left ventricular musce mass
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2020.
- Derived from this study: PubMed 30190005Meister TA, Rimoldi SF, Soria R, von Arx R, Messerli FH, Sartori C, Scherrer U, Rexhaj E. Association of Assisted Reproductive Technologies With Arterial Hypertension During Adolescence. J Am Coll Cardiol. 2018 Sep 11;72(11):1267-1274. doi: 10.1016/j.jacc.2018.06.060.
- Derived from this study: PubMed 22434595Scherrer U, Rimoldi SF, Rexhaj E, Stuber T, Duplain H, Garcin S, de Marchi SF, Nicod P, Germond M, Allemann Y, Sartori C. Systemic and pulmonary vascular dysfunction in children conceived by assisted reproductive technologies. Circulation. 2012 Apr 17;125(15):1890-6. doi: 10.1161/CIRCULATIONAHA.111.071183. Epub 2012 Mar 20.
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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.
Emrush Rexhaj, PD principal investigator
University Hospital of Bern, Cardiology, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility, run by University of Lausanne Hospitals at 1 site in Switzerland.
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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 20 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Urs Scherrer, Prof (+4131 632 2111, Urs.Scherrer2@insel.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac function (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00837642, which also lists 2 linked publications.
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 20 Feb 2020.