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Active, Not Recruiting

NCT Number: NCT03799107

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Infertility Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Diseases, Male Infertility Primary Infertility Secondary Infertility Unexplained Infertility, Female Infertility, Male Male Urogenital Diseases Urogenital Diseases

Age range

4 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of California, San Francisco

San Francisco, California, 94115, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Metabolic testing of child - fasting glucose

    Time frame: 1 day at study visit

    Fasting glucose mg/dL

  2. Metabolic testing of child - fasting insulin

    Time frame: 1 day at study visit

    Fasting insulin uIU/mL

  3. Metabolic testing of child - uric acid

    Time frame: 1 day at study visit

    uric acid mg/dL

  4. Metabolic testing of child - total cholesterol

    Time frame: 1 day at study visit

    Cholesterol, Total mg/dL

  5. Metabolic testing of child - HDL cholesterol

    Time frame: 1 day at study visit

    HDL cholesterol mg/dL

  6. Metabolic testing of child - LDL cholesterol

    Time frame: 1 day at study visit

    LDL cholesterol mg/dL

  7. Metabolic testing of child - Triglycerides

    Time frame: 1 day at study visit

    Triglycerides mg/dL

  8. Metabolic testing of child - cholesterol ratio

    Time frame: 1 day at study visit

    CHOL/HDLC ratio

  9. Metabolic testing of child - non-HDL cholesterol

    Time frame: 1 day at study visit

    Non-HDL cholesterol mg/dL

  10. Metabolic testing of child - Alanine Aminotransferase

    Time frame: 1 day at study visit

    Alanine Aminotransferase (ALT) U/L

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Official study title

The Developmental Epidemiological Study of Children Born Through Reproductive Technology

Acronym: DESCRT

Important dates

Study start
2017
Primary completion
2025
Study completion
2025
First posted
Jan 10, 2019
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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