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

The Developmental Epidemiological Study of Children Born Through Reproductive Technology

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Infertility; Infertility, Female; Infertility, Male; Infertility Unexplained; Infertility Primary; Infertility Secondary

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.

• Study Type: Observational
• Enrollment (Estimated): 3700

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94115
      • University of California, San Francisco

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Retrospective; Children born with assistance
Prospective; People who have sought evaluation/treatment for infertility

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (Actual): July 14, 2017
• Primary Completion (Actual): December 1, 2023
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: November 15, 2018
• First Submitted That Met QC Criteria: January 9, 2019
• First Posted (Actual): January 10, 2019

Study Record Updates

• Last Update Posted (Estimated): January 23, 2024
• Last Update Submitted That Met QC Criteria: January 19, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Genital Diseases, Female; Infertility; Infertility, Female; Infertility, Male
• Other Study ID Numbers: IRB 16-20474

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No