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

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ClinicalTrials.gov Identifier: NCT03799107
Recruitment Status : Recruiting
First Posted : January 10, 2019
Last Update Posted : January 10, 2019
Sponsor:
Information provided by (Responsible Party):
Marcell Cedars, M.D., 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.

Condition or disease
Infertility Infertility, Female Infertility, Male Infertility Primary Infertility Secondary Infertility Unexplained

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
Estimated 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 : July 14, 2017
Estimated Primary Completion Date : January 1, 2020
Estimated Study Completion Date : January 1, 2020


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



Primary Outcome Measures :
  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



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Ages Eligible for Study:   4 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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

Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03799107


Contacts
Contact: Study coordinator 415.476.3798 descrt@ucsf.edu

Locations
United States, California
University of California, San Francisco Recruiting
San Francisco, California, United States, 94115
Contact: Marcelle I. Cedars, MD    415-353-7475    cedarsm@obgyn.ucsf.edu   
Principal Investigator: Marcelle I. Cedars, MD         
Sponsors and Collaborators
University of California, San Francisco

Responsible Party: Marcell Cedars, M.D., Director, Center for Reproductive Health, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03799107     History of Changes
Other Study ID Numbers: IRB 16-20474
First Posted: January 10, 2019    Key Record Dates
Last Update Posted: January 10, 2019
Last Verified: January 2019

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Infertility
Infertility, Female
Infertility, Male
Genital Diseases, Male
Genital Diseases, Female