NCT03799107

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
3,700

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 14, 2017

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

November 15, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 10, 2019

Completed
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

8 years

First QC Date

November 15, 2018

Last Update Submit

September 9, 2024

Conditions

InfertilityInfertility, FemaleInfertility, MaleInfertility PrimaryInfertility SecondaryInfertility Unexplained

Outcome Measures

Primary Outcomes (10)

  • Metabolic testing of child - fasting glucose

    Fasting glucose mg/dL

    1 day at study visit

  • Metabolic testing of child - fasting insulin

    Fasting insulin uIU/mL

    1 day at study visit

  • Metabolic testing of child - uric acid

    uric acid mg/dL

    1 day at study visit

  • Metabolic testing of child - total cholesterol

    Cholesterol, Total mg/dL

    1 day at study visit

  • Metabolic testing of child - HDL cholesterol

    HDL cholesterol mg/dL

    1 day at study visit

  • Metabolic testing of child - LDL cholesterol

    LDL cholesterol mg/dL

    1 day at study visit

  • Metabolic testing of child - Triglycerides

    Triglycerides mg/dL

    1 day at study visit

  • Metabolic testing of child - cholesterol ratio

    CHOL/HDLC ratio

    1 day at study visit

  • Metabolic testing of child - non-HDL cholesterol

    Non-HDL cholesterol mg/dL

    1 day at study visit

  • Metabolic testing of child - Alanine Aminotransferase

    Alanine Aminotransferase (ALT) U/L

    1 day at study visit

Study Arms (2)

Retrospective

Children born with assistance

Prospective

People who have sought evaluation/treatment for infertility

Eligibility Criteria

Age4 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Retrospective: \- children conceived by parent(s) who sought evaluation/treatment for infertility Prospective: \- people seeking evaluation/treatment for infertility

You may qualify if:

  • \- children conceived by parent(s) who sought evaluation/treatment for infertility

You may not qualify if:

  • \- Children with chronic medical illnesses that prevent a study visit
  • Prospective arm
  • \- seeking evaluation/treatment for infertility
  • \- none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94115, United States

Location

Related Publications (1)

  • Adeleye AJ, Zablotska L, Rinaudo P, Huang D, Lustig RH, Cedars MI. Study protocol for a Developmental Epidemiological Study of Children born through Reproductive Technologies (DESCRT). Hum Reprod Open. 2023 May 5;2023(2):hoad013. doi: 10.1093/hropen/hoad013. eCollection 2023.

    PMID: 37265937DERIVED

MeSH Terms

Conditions

InfertilityInfertility, FemaleInfertility, Male

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsGenital Diseases, MaleMale Urogenital Diseases

Study Officials

  • Marcelle Cedars, MD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 15, 2018

First Posted

January 10, 2019

Study Start

July 14, 2017

Primary Completion

July 1, 2025

Study Completion

July 1, 2025

Last Updated

September 19, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)