Infertility, Infertility, Female, Infertility, Male, Infertility Primary, Infertility Secondary, Infertility Unexplained
Conditions
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.
Interventions
None listed
Sponsors
University of California, San Francisco
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
4 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Metabolic testing of child - fasting glucose | 1 day at study visit | Fasting glucose mg/dL |
| Metabolic testing of child - fasting insulin | 1 day at study visit | Fasting insulin uIU/mL |
| Metabolic testing of child - uric acid | 1 day at study visit | uric acid mg/dL |
| Metabolic testing of child - total cholesterol | 1 day at study visit | Cholesterol, Total mg/dL |
| Metabolic testing of child - HDL cholesterol | 1 day at study visit | HDL cholesterol mg/dL |
| Metabolic testing of child - LDL cholesterol | 1 day at study visit | LDL cholesterol mg/dL |
| Metabolic testing of child - Triglycerides | 1 day at study visit | Triglycerides mg/dL |
| Metabolic testing of child - cholesterol ratio | 1 day at study visit | CHOL/HDLC ratio |
| Metabolic testing of child - non-HDL cholesterol | 1 day at study visit | Non-HDL cholesterol mg/dL |
| Metabolic testing of child - Alanine Aminotransferase | 1 day at study visit | Alanine Aminotransferase (ALT) U/L |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMarcelle Cedars, MD
University of California, San Francisco
Outcome results
None listed