Developmental Epidemiological Study of Children Born Through Reproductive Technology

Active, not recruiting

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

• Registration Number: NCT03799107
• Lead Sponsor: University of California, San Francisco

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.

Study Timeline

• Study Start: 2017-07-14
• Study First Submitted: 2018-11-15
• Study First Submitted QC: 2019-01-09
• Study First Posted: 2019-01-10
• Primary Completion: 2023-12-01
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-19
• Last Update Posted: 2024-01-23
• Study Completion: 2024-07-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 3700

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 - 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 - LDL cholesterol	1 day at study visit	LDL cholesterol mg/dL
Metabolic testing of child - fasting insulin	1 day at study visit	Fasting insulin uIU/mL
Metabolic testing of child - Triglycerides	1 day at study visit	Triglycerides mg/dL
Metabolic testing of child - Alanine Aminotransferase	1 day at study visit	Alanine Aminotransferase (ALT) U/L
Metabolic testing of child - fasting glucose	1 day at study visit	Fasting glucose mg/dL
Metabolic testing of child - uric acid	1 day at study visit	uric acid mg/dL

Trial Locations

Locations (1)

University of California, San Francisco; 🇺🇸 San Francisco, California, United States