The Developmental Epidemiological Study of Children Born Through Reproductive Technology
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.
Investigators
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