Clinical trial NCT03799107: Developmental Epidemiological Study of Children Born Through Reproductive Technology
Official title: The Developmental Epidemiological Study of Children Born Through Reproductive Technology
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Infertility
Infertility, Female
Infertility, Male
Infertility Primary
Infertility Secondary
Infertility Unexplained
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2019-01-10
Enrollment: 3700
Sex: ALL
Minimum age (years): 4
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Retrospective:

- children conceived by parent(s) who sought evaluation/treatment for infertility

Prospective:

- people seeking evaluation/treatment for infertility

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.

Eligibility 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

Exclusion criteria:

- none

Primary outcomes:
measure: Metabolic testing of child - fasting glucose
timeFrame: 1 day at study visit
measure: Metabolic testing of child - fasting insulin
timeFrame: 1 day at study visit
measure: Metabolic testing of child - uric acid
timeFrame: 1 day at study visit
measure: Metabolic testing of child - total cholesterol
timeFrame: 1 day at study visit
measure: Metabolic testing of child - HDL cholesterol
timeFrame: 1 day at study visit
measure: Metabolic testing of child - LDL cholesterol
timeFrame: 1 day at study visit
measure: Metabolic testing of child - Triglycerides
timeFrame: 1 day at study visit
measure: Metabolic testing of child - cholesterol ratio
timeFrame: 1 day at study visit
measure: Metabolic testing of child - non-HDL cholesterol
timeFrame: 1 day at study visit
measure: Metabolic testing of child - Alanine Aminotransferase
timeFrame: 1 day at study visit
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Marcelle Cedars, MD
role: PRINCIPAL_INVESTIGATOR
References: