Vascular Dysfunction in Offspring of Assisted Reproduction Technologies

Infertility Clinical Trial

Official title:

Vascular Dysfunction in Offspring of Assisted Reproduction Technologies

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00837642
• Other study ID #: 35/07
• Status: Recruiting
• Start date: October 2008
• Est. completion date: June 2021

Study information

• Verified date: February 2020
• Source: University of Lausanne Hospitals
• Contact: Urs Scherrer, Prof
• Phone: +4131 632 2111
• Email: Urs.Scherrer2[@]insel.ch
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 2021
• Est. primary completion date: December 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Offspring of ART

• Healthy

• Born at term

Exclusion Criteria:

• Cardio-pulmonary malformations

• Neuro-muscular malformations

Related Conditions & MeSH terms

• Infertility

Intervention

Diagnostic Test:
• Transthoracic echocardiography
Full transthoracic echocardiography will be performed.

Locations

Country	Name	City	State
Switzerland	University Hospital	Bern	BE

Sponsors (1)

Lead Sponsor	Collaborator
University of Lausanne Hospitals

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiac function	Ejection fraction [%]	1 year
Secondary	Left ventricular musce mass	Left ventricular muscle mass [g/m2]	1 year