Developmental Epidemiological Study of Children Born Through Reproductive Technology

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Developmental Epidemiological Study of Children Born Through Reproductive Technology

Conditions
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Infertility, Infertility, Female, Infertility, Male, Infertility Primary, Infertility Secondary, Infertility Unexplained

Participation Criteria
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Eligibility Criteria
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Retrospective arm Inclusion criteria: - children conceived by parent(s) who sought evaluation/treatment for infertility Exclusion criteria: - Children with chronic medical illnesses that prevent a study visit Prospective arm Inclusion criteria: - seeking evaluation/treatment for infertility Exclusion criteria: - none

Ages Eligible for Study
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Minimum Age: 4 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Retrospective<br>Children born with assistance | |
| Prospective<br>People who have sought evaluation/treatment for infertility | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metabolic testing of child - fasting glucose | Fasting glucose mg/dL | 1 day at study visit | 
| Metabolic testing of child - fasting insulin | Fasting insulin uIU/mL | 1 day at study visit | 
| Metabolic testing of child - uric acid | uric acid mg/dL | 1 day at study visit | 
| Metabolic testing of child - total cholesterol | Cholesterol, Total mg/dL | 1 day at study visit | 
| Metabolic testing of child - HDL cholesterol | HDL cholesterol mg/dL | 1 day at study visit | 
| Metabolic testing of child - LDL cholesterol | LDL cholesterol mg/dL | 1 day at study visit | 
| Metabolic testing of child - Triglycerides | Triglycerides mg/dL | 1 day at study visit | 
| Metabolic testing of child - cholesterol ratio | CHOL/HDLC ratio | 1 day at study visit | 
| Metabolic testing of child - non-HDL cholesterol | Non-HDL cholesterol mg/dL | 1 day at study visit | 
| Metabolic testing of child - Alanine Aminotransferase | Alanine Aminotransferase (ALT) U/L | 1 day at study visit |