DESCRT: Developmental Epidemiological Study of Children Born Through Reproductive Technology

Sponsor
University of California, San Francisco (Other)
Overall Status
Recruiting
CT.gov ID
NCT03799107
Collaborator
(none)
3,700
1
83.6
44.3

Study Details

Study Description

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 Design

Study Type:
Observational
Anticipated Enrollment :
3700 participants
Observational Model:
Cohort
Time Perspective:
Other
Official Title:
The Developmental Epidemiological Study of Children Born Through Reproductive Technology
Actual Study Start Date :
Jul 14, 2017
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Jul 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Retrospective

Children born with assistance

Prospective

People who have sought evaluation/treatment for infertility

Outcome Measures

Primary Outcome Measures

  1. Metabolic testing of child - fasting glucose [1 day at study visit]

    Fasting glucose mg/dL

  2. Metabolic testing of child - fasting insulin [1 day at study visit]

    Fasting insulin uIU/mL

  3. Metabolic testing of child - uric acid [1 day at study visit]

    uric acid mg/dL

  4. Metabolic testing of child - total cholesterol [1 day at study visit]

    Cholesterol, Total mg/dL

  5. Metabolic testing of child - HDL cholesterol [1 day at study visit]

    HDL cholesterol mg/dL

  6. Metabolic testing of child - LDL cholesterol [1 day at study visit]

    LDL cholesterol mg/dL

  7. Metabolic testing of child - Triglycerides [1 day at study visit]

    Triglycerides mg/dL

  8. Metabolic testing of child - cholesterol ratio [1 day at study visit]

    CHOL/HDLC ratio

  9. Metabolic testing of child - non-HDL cholesterol [1 day at study visit]

    Non-HDL cholesterol mg/dL

  10. Metabolic testing of child - Alanine Aminotransferase [1 day at study visit]

    Alanine Aminotransferase (ALT) U/L

Eligibility Criteria

Criteria

Ages Eligible for Study:
4 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of California, San Francisco San Francisco California United States 94115

Sponsors and Collaborators

  • University of California, San Francisco

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT03799107
Other Study ID Numbers:
  • IRB 16-20474
First Posted:
Jan 10, 2019
Last Update Posted:
Nov 12, 2021
Last Verified:
Nov 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 12, 2021