Vascular Dysfunction in Offspring of Assisted Reproduction Technologies

NCT ID: NCT00837642

Last Updated: 2020-02-20

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-10-31
• Study Completion Date: 2021-06-30

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.

Conditions

Infertility

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

ART (Assited reproductive technologies)

In participants born after IVF will be performed a transthoracic echocardiography

Transthoracic echocardiography

Intervention Type: DIAGNOSTIC_TEST

Full transthoracic echocardiography will be performed.

Control

In participants naturally conceived will be performed a transthoracic echocardiography

Transthoracic echocardiography

Intervention Type: DIAGNOSTIC_TEST

Full transthoracic echocardiography will be performed.

Interventions

Transthoracic echocardiography

Full transthoracic echocardiography will be performed.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Offspring of ART
• Healthy
• Born at term

Exclusion Criteria

• Cardio-pulmonary malformations
• Neuro-muscular malformations

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Lausanne Hospitals

OTHER

Sponsor Role: lead

Responsible Party

Urs Scherrer

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Emrush Rexhaj, PD

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Bern, Cardiology, Switzerland

Locations

University Hospital

Bern, Canton of Bern, Switzerland

Site Status: RECRUITING

Countries

Switzerland

Central Contacts

Urs Scherrer, Prof

Role: CONTACT

Urs.Scherrer2@insel.ch

+4131 632 2111

Emrush Rexhaj, PD

Role: CONTACT

emrush.rexhaj@insel.ch

+4131 632 2111

Facility Contacts

Emrush Rexhaj, PD

Role: primary

emrush.rexhaj@insel.ch

+4131 632 21 11

References

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.

Reference Type: DERIVED

PMID: 30190005 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 22434595 (View on PubMed)

Other Identifiers

35/07

Identifier Type: -

Identifier Source: org_study_id