Genetics of Differences of Sex Development and Hypospadias

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Boston Children's Hospital
Study ID
NCT03102554
Status
Enrolling By Invitation

Conditions

  • Disorders of Sex Development
  • Hypospadias

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Return of Genetic Results — GENETIC
    The results of testing for genetic causes of DSD/hypospadias will be returned to parents of subjects who elect to receive these results.

Study Details

This study seeks to identify genetic causes of conditions that affect the gonads and genitals, and to study the impact on families of receiving genetic results.

Key Dates

Start date
Jan 1, 2018
Status verified
Jun 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
300 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Genetic Testing
    Subjects will provide a DNA sample, which will be screened for variants in genes related to DSD/hypospadias. Probands/parents who wish to receive results of genetic testing related to DSD/hypospadias will receive these results directly from the research study. Parents who receive results of genetic testing for probands 17 years old or younger will complete questionnaires at the time of enrollment, right after receiving genetic results, and 3 months after receiving genetic results.

Primary Outcome Measure

Decision Regret [ Time Frame: 3 months after return of genetic results ]

Locations (1)

FacilityCityStateZIPSite coordinators
Boston Children's HospitalBostonMassachusetts02115-

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By research site
Boston Children's Hospital· Boston, MA

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