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Genetic Results for Intersex Conditions

N/A

Waitlist Available

Led By Yee-Ming Chan, MD, PhD

Research Sponsored by Boston Children's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Genital or gonadal abnormalities as evidenced by physical examination or imaging (including but not limited to hypospadias, microphallus, clitoromegaly, ambiguous genitalia), with no cause identified by standard clinical evaluation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months after return of genetic results compared to baseline

Awards & highlights

Study Summary

This trial will help researchers learn more about conditions that can affect the gonads and genitals, and how families react to learning genetic results.

Who is the study for?

This trial is for individuals with unexplained abnormalities of the genitals or gonads, such as hypospadias or ambiguous genitalia. Participants must have had these conditions confirmed by physical exam or imaging and lack a diagnosis from standard clinical evaluations.Check my eligibility

What is being tested?

The study aims to find genetic reasons behind different sex development conditions and hypospadias. It also looks at how families are affected when they receive genetic information about these conditions.See study design

What are the potential side effects?

Since this trial involves returning genetic results rather than testing medications, there aren't typical drug side effects. However, receiving sensitive genetic information may have emotional or psychological impacts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have unexplained abnormalities in my reproductive organs.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months after return of genetic results

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months after return of genetic results

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months after return of genetic results for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Decision Regret

Secondary outcome measures

Anxiety

Child Health-Related Stress

Depression

+5 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Genetic TestingExperimental Treatment1 Intervention

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.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Boston Children's HospitalLead Sponsor

761 Previous Clinical Trials

5,579,430 Total Patients Enrolled

Yee-Ming Chan, MD, PhD5.02 ReviewsPrincipal Investigator - Boston Children's Hospital

Boston Children's Hospital

5Patient Review

Dr. Chan is very comforting and always makes sure we are well-informed. I would highly recommend him to anyone.

Media Library

Return of Genetic Results Clinical Trial Eligibility Overview. Trial Name: NCT03102554 — N/A

Intersex Conditions Research Study Groups: Genetic Testing

Intersex Conditions Clinical Trial 2023: Return of Genetic Results Highlights & Side Effects. Trial Name: NCT03102554 — N/A

Return of Genetic Results 2023 Treatment Timeline for Medical Study. Trial Name: NCT03102554 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the research group currently enrolling participants for this trial?

"Correct. Clinicaltrials.gov shows that this study is recruiting participants, with the initial post dating back to January 1st 2018 and the most recent update being on November 1st 2022. A total of 300 individuals are needed at one clinical trial site."

Answered by AI

How many human participants are involved in this clinical investigation?

"Affirmative. Clinicaltrials.gov's records show that this clinical trial, which was first advertised on 1/1/2018 and revised lastly on 1/11/2022 is actively seeking applicants. Around 300 individuals need to be recruited from one primary site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Genetics of Differences of Sex Development and Hypospadias

Yee-Ming Chan 2018. "Genetics of Differences of Sex Development and Hypospadias". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03102554.