Vascular Dysfunction in Offspring of Assisted Reproduction Technologies

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 Overview

• Status: Unknown
• Conditions: Infertility
• Intervention / Treatment: Diagnostic test: Transthoracic echocardiography

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Urs Scherrer, Prof; Phone Number: +4131 632 2111; Email: Urs.Scherrer2@insel.ch
• Study Contact Backup: Name: Emrush Rexhaj, PD; Phone Number: +4131 632 2111; Email: emrush.rexhaj@insel.ch

Study Locations

• Switzerland
  • BE
    • Bern, BE, Switzerland, 3010
      • Recruiting
      • University Hospital
      • Contact: Emrush Rexhaj, PD; Phone Number: +4131 632 21 11; Email: emrush.rexhaj@insel.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

Inclusion Criteria:

• Offspring of ART
• Healthy
• Born at term

Exclusion Criteria:

• Cardio-pulmonary malformations
• Neuro-muscular malformations

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ART (Assited reproductive technologies); In participants born after IVF will be performed a transthoracic echocardiography	Diagnostic test: Transthoracic echocardiography; Full transthoracic echocardiography will be performed.
Control; In participants naturally conceived will be performed a transthoracic echocardiography	Diagnostic test: Transthoracic echocardiography; Full transthoracic echocardiography will be performed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiac function	Ejection fraction [%]	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Left ventricular musce mass	Left ventricular muscle mass [g/m2]	1 year

Collaborators and Investigators

• Sponsor: University of Lausanne Hospitals
• Investigators: Principal Investigator: Emrush Rexhaj, PD, University Hospital of Bern, Cardiology, Switzerland

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): June 1, 2021

Study Registration Dates

• First Submitted: February 4, 2009
• First Submitted That Met QC Criteria: February 4, 2009
• First Posted (Estimate): February 5, 2009

Study Record Updates

• Last Update Posted (Actual): February 20, 2020
• Last Update Submitted That Met QC Criteria: February 19, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Vascular function in offspring of ART
• Additional Relevant MeSH Terms: Infertility
• Other Study ID Numbers: 35/07