Developmental Epidemiological Study of Children Born Through Reproductive Technology

Infertility Clinical Trial

— DESCRT  

Official title:

The Developmental Epidemiological Study of Children Born Through Reproductive Technology

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03799107
• Other study ID #: IRB 16-20474
• Status: Active, not recruiting
• Start date: July 14, 2017
• Est. completion date: July 1, 2024

Study information

• Verified date: January 2024
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 3700
• Est. completion date: July 1, 2024
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Infertility
• Infertility Primary
• Infertility Secondary
• Infertility Unexplained
• Infertility, Female
• Infertility, Male

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Metabolic testing of child - fasting glucose	Fasting glucose mg/dL	1 day at study visit
Primary	Metabolic testing of child - fasting insulin	Fasting insulin uIU/mL	1 day at study visit
Primary	Metabolic testing of child - uric acid	uric acid mg/dL	1 day at study visit
Primary	Metabolic testing of child - total cholesterol	Cholesterol, Total mg/dL	1 day at study visit
Primary	Metabolic testing of child - HDL cholesterol	HDL cholesterol mg/dL	1 day at study visit
Primary	Metabolic testing of child - LDL cholesterol	LDL cholesterol mg/dL	1 day at study visit
Primary	Metabolic testing of child - Triglycerides	Triglycerides mg/dL	1 day at study visit
Primary	Metabolic testing of child - cholesterol ratio	CHOL/HDLC ratio	1 day at study visit
Primary	Metabolic testing of child - non-HDL cholesterol	Non-HDL cholesterol mg/dL	1 day at study visit
Primary	Metabolic testing of child - Alanine Aminotransferase	Alanine Aminotransferase (ALT) U/L	1 day at study visit