Clinical trial NCT00837642: Vascular Dysfunction in Offspring of Assisted Reproduction Technologies
Official title: Vascular Dysfunction in Offspring of Assisted Reproduction Technologies
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Infertility
Keywords: Vascular function in offspring of ART
Lead sponsor: University of Lausanne Hospitals
Sponsor class: OTHER
First posted: 2009-02-05
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All the partcicipants that have been participated in our previous studies will be asked to take part in this new study.

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.


Eligibility criteria: Inclusion Criteria:

* Offspring of ART
* Healthy
* Born at term

Exclusion Criteria:

* Cardio-pulmonary malformations
* Neuro-muscular malformations

Primary outcomes:
measure: Cardiac function
timeFrame: 1 year
Secondary outcomes:
measure: Left ventricular musce mass
timeFrame: 1 year
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: University Hospital
state: BE
Study officials:
affiliation: University Hospital of Bern, Cardiology, Switzerland
name: Emrush Rexhaj, PD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Scherrer 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.