Developmental Epidemiological Study of Children Born Through Reproductive Technology (DESCRT)

University of California San Francisco (UCSF)

Status: Active, not recruiting

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

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT03799107

IRB 16-20474

1R01HD084380 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3,700 estimated patients

Sex: All

Ages: 4+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

3,700 participants in 2 patient groups

Retrospective

Description:

Children born with assistance

Prospective

Description:

People who have sought evaluation/treatment for infertility