Vascular Dysfunction in Offspring of Assisted Reproduction Technologies
1 other identifier
observational
100
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Oct 2008
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2008
CompletedFirst Submitted
Initial submission to the registry
February 4, 2009
CompletedFirst Posted
Study publicly available on registry
February 5, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2021
CompletedFebruary 20, 2020
February 1, 2020
12.2 years
February 4, 2009
February 19, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Cardiac function
Ejection fraction \[%\]
1 year
Secondary Outcomes (1)
Left ventricular musce mass
1 year
Study Arms (2)
ART (Assited reproductive technologies)
In participants born after IVF will be performed a transthoracic echocardiography
Control
In participants naturally conceived will be performed a transthoracic echocardiography
Interventions
Full transthoracic echocardiography will be performed.
Eligibility Criteria
All the partcicipants that have been participated in our previous studies will be asked to take part in this new study.
You may qualify if:
- Offspring of ART
- Healthy
- Born at term
You may not qualify if:
- Cardio-pulmonary malformations
- Neuro-muscular malformations
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital
Bern, Canton of Bern, 3010, Switzerland
Related Publications (2)
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.
PMID: 30190005DERIVEDScherrer 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.
PMID: 22434595DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Emrush Rexhaj, PD
University Hospital of Bern, Cardiology, Switzerland
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
February 4, 2009
First Posted
February 5, 2009
Study Start
October 1, 2008
Primary Completion
December 1, 2020
Study Completion
June 1, 2021
Last Updated
February 20, 2020
Record last verified: 2020-02