Lausanne, Switzerland


Purpose:

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. Preliminary data from our group 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. Therefore, the major goal of our proposal is to test the hypothesis that apparently healthy children born after ART display vascular dysfunction of both the pulmonary and the systemic circulation.


Criteria:

Inclusion Criteria: - Offspring of ART - Healthy - No medication - Born at term Exclusion Criteria: - Cardio-pulmonary malformations - Neuro-muscular malformations - Previous high altitude diseases


Study is Available At:


Original ID:

35/07


NCT ID:

NCT00837642


Secondary ID:


Study Acronym:


Brief Title:

Vascular Dysfunction in Offspring of Assisted Reproduction Technologies


Official Title:

Vascular Dysfunction in Offspring of Assisted Reproduction Technologies


Overall Status:

Recruiting


Study Phase:

N/A


Genders:

Both


Minimum Age:

10 Years


Maximum Age:

18 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Lausanne Hospitals


Oversight Authority:

Switzerland: Federal Office of Public Health


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

N/A


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

0


Enrollment Type:


Overall Contact Information

Primary Contact:Urs Scherrer, Prof
+4121 314 09 30
Urs.Scherrer@chuv.ch
Backup Contact:Claudio Sartori, Prof
+4121 314 09 30
Claudio.Sartori@chuv.ch

Study Dates

Start Date:March 2008
Completion Date:December 2009
Completion Type:Anticipated
Primary Completion Date:April 2009
Primary Completion Type:Anticipated
Verification Date:January 2009
Last Changed Date:February 4, 2009
First Received Date:February 4, 2009

Study Outcomes

Outcome Type:Primary Outcome
Measure:Endothelial function
Safety Issues:False

Study Interventions

Intervention Type:Dietary Supplement
Name:Vitamin C and E

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Lausanne Hospitals

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: November 17, 2017

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