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Clinical Trials/NCT03799107
NCT03799107
Active, not recruiting
Not Applicable

The Developmental Epidemiological Study of Children Born Through Reproductive Technology

University of California, San Francisco1 site in 1 country3,700 target enrollmentJuly 14, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Infertility
Sponsor
University of California, San Francisco
Enrollment
3700
Locations
1
Primary Endpoint
Metabolic testing of child - LDL cholesterol
Status
Active, not recruiting
Last Updated
2 years ago

Overview

Brief Summary

DESCRT will be a long-term study that both looks back in time, at successful pregnancies, and forward in time at early pregnancy and long-term as these children grow. Currently, there are limited data on the long-term effects of infertility and infertility treatments on children. There are some studies to suggest that these children may have altered metabolic profiles, but this study aims to be the largest study to answer this question.

Detailed Description

Over the past 30 years, much of the research and clinical effort in the field of ART had to do with improving outcome in terms of successful pregnancy. However, as these rates have increased, attention is slowly turning to focus on the health of the resultant child. Short-term health complications, in particular birth defects,have been well-described. However, even this "hard" outcome has been difficult to characterize as studies used different methodologies, varied age of detection, and frequently didn't have an appropriate comparison group. When underlying parental factors and infertility are included in the analyses, the association is substantially weakened or disappears completely. This exemplifies the problems with much of the currently available research regarding childhood outcomes following ART. While the health of children born through these technologies is of critical public health interest, and of personal interest to families, only limited data exist. In order to evaluate the potential risk to long-term health of children conceived through assisted reproductive technologies (ART) and non-IVF fertility treatments (NIFT), rigorous epidemiological methods, appropriate characterization of the exposure, standardized collection of outcome data, and appropriate comparison groups are required. The proposed Developmental Epidemiological Study of Children born through Reproductive Technology (DESCRT) is aimed to carefully address these important characteristics.

Registry
clinicaltrials.gov
Start Date
July 14, 2017
End Date
July 1, 2024
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Metabolic testing of child - LDL cholesterol

Time Frame: 1 day at study visit

LDL cholesterol mg/dL

Metabolic testing of child - fasting insulin

Time Frame: 1 day at study visit

Fasting insulin uIU/mL

Metabolic testing of child - Triglycerides

Time Frame: 1 day at study visit

Triglycerides mg/dL

Metabolic testing of child - Alanine Aminotransferase

Time Frame: 1 day at study visit

Alanine Aminotransferase (ALT) U/L

Metabolic testing of child - fasting glucose

Time Frame: 1 day at study visit

Fasting glucose mg/dL

Metabolic testing of child - uric acid

Time Frame: 1 day at study visit

uric acid mg/dL

Metabolic testing of child - total cholesterol

Time Frame: 1 day at study visit

Cholesterol, Total mg/dL

Metabolic testing of child - HDL cholesterol

Time Frame: 1 day at study visit

HDL cholesterol mg/dL

Metabolic testing of child - cholesterol ratio

Time Frame: 1 day at study visit

CHOL/HDLC ratio

Metabolic testing of child - non-HDL cholesterol

Time Frame: 1 day at study visit

Non-HDL cholesterol mg/dL

Study Sites (1)

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