Fertility Attitudes of Adolescents and Young Adults With Turner Syndrome and Their Parents/Guardians (The Fertility ConcepTS Study)

June 15, 2023 updated by: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Background:

Turner syndrome (TS) is caused by the partial or complete absence of one of the two X

chromosomes in all cells or a portion of cells. Adolescents and young adults (AYAs) with TS and their families are not routinely counseled about fertility issues and options. Researchers want to learn more about the attitudes of AYAs with TS and their parents or guardians regarding future fertility.

Objective:

To create and distribute a survey for AYAs with TS and their parents or guardians that will improve understanding about their attitudes toward fertility, fertility preservation, and options for building a family.

Eligibility:

Female AYAs aged 12-25 years with TS, and parents or guardians of AYAs with TS.

Design:

Participants will be put into 3 focus groups: females ages 12-17 with TS; females ages 18-25 with TS; and parents or guardians of AYAs with TS. Each focus group session will be held via Zoom. Participants can use video or just audio for the session. They will use their first name. If they prefer, they can use a pseudonym. Each group will meet once. The session will last 90 minutes.

Participants will receive a draft of the survey. The survey questions ask about fertility and pregnancy. Participants will evaluate the usefulness and relevance of each question. They will be asked if any question should be changed. The survey will be finalized based on their feedback. The final survey will be distributed through TS groups.

Participation will last for 1 day....

Study Overview

Status

Completed

Conditions

Detailed Description

This study aims to improve our understanding of attitudes of adolescents and young adults (AYA) with Turner Syndrome and their parents/guardians towards fertility, fertility preservation, and options for building a family through development and dissemination of a fertility attitudes questionnaire.

Primary Objective: To compare differences in attitudes between AYA with TS and their parents regarding survey content area (i) medical/surgical fertility preservation procedures with unknown outcomes.

Secondary Objectives:

  1. To compare differences in attitudes between AYA with TS and their parents regarding survey content areas (ii) interest in understanding the effects of TS on fertility and pregnancy and (iii) opinions of having children that are genetically similar and alternative methods of building a family.
  2. To compare differences in attitudes between adolescents aged 12-17 years and young adults aged 18-25 years with TS regarding survey content areas (i) medical/surgical fertility preservation procedures with unknown outcomes, (ii) interest in understanding the effects of TS on fertility and pregnancy, and (iii) opinions of having children that are genetically similar and alternative methods of building a family.

Primary Endpoint: Difference in response scores between AYA with TS-parent dyads to the survey questions addressing survey content area (i) interest in medical/surgical fertility preservation procedures with unknown outcomes.

Secondary Endpoints:

  1. Differences in response scores between AYA with TS-parent dyads to the survey questions addressing survey content areas

    (ii) interest in understanding the effects of TS on fertility and pregnancy, and (iii) opinions of having children that are genetically similar and alternative methods of building a family.

  2. Differences in response scores between adolescents with TS ages 12 to 17 years and young adults with TS ages 18 to 25 years to the survey content areas addressing (i) interest in medical/surgical fertility preservation procedures with unknown outcomes, (ii) interest in understanding the effects of TS on fertility and pregnancy, and (iii) opinions of having children that are genetically similar and alternative methods of building a family

Study Type

Observational

Enrollment (Actual)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20892
        • National Institute of Child Health and Human Development (NICHD)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 25 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

For the three focus groups, participants will consist of adolescents and young adults with Turner Syndrome and their parents/guardians recruited from members of the Turner Syndrome Global Alliance (TSGA) by their leadership. An IRB-approved flyer will be sent to the TSGA for distribution to their members. The Fertility Attitudes survey will be disseminated by various TS support groups through a link for the survey webpage and an IRB-approved flyer with a QR code and link to an online survey webpage via the Clinical Trials Survey System (CTSS) provided to their members via their email as well as through their social media site (Facebook page).

Description

  • INCLUSION CRITERIA:

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

  1. Stated willingness to comply with all study procedures and availability for the duration ofthe study
  2. Adolescents and young adults ages 12 to 25 years who self- identify as having Turnersyndrome
  3. Individuals who self-identity as parents/guardians of adolescents and young adults ages12 to 25 years with Turner syndrome

EXCLUSION CRITERIA:

Inability to read and comprehend written and Verbal English as the surveys required for the study have not been translated for non-English speaking subjects.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Adolescents (12-17)
Adolescents 12-17 with Turner Syndrome
Parents of Adolescents (12-17)
Parents of Adolescents (12-17)with Turner Syndrome
Young Adults (18-25)
Young Adults (18-25)with Turner Syndrome

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SURVEY CONTENT
Time Frame: Baseline
To compare differences in survey response scores between adolescents/young adults with TS and their parents regarding survey content areas (i) medical/surgical fertility preservation procedures with unknown outcomes.
Baseline
SURVEY CONTENT
Time Frame: Baseline
Differences in attitudes between AYA with TS and their parents regarding survey content area (i) medical/surgical fertility preservation procedures with unknown outcomes
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
RESPONSE SCORES
Time Frame: Baseline
Differences in responses between AYA with TS and their parents to the survey content
Baseline
RESPONSE SCORES
Time Frame: Baseline
Differences in responses between adolescents aged 12-17 years and young adults aged 18-25 years with TS regarding survey content
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Investigators

  • Principal Investigator: Veronica Gomez-Lobo, M.D., Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 25, 2022

Primary Completion (Actual)

June 12, 2023

Study Completion (Actual)

June 12, 2023

Study Registration Dates

First Submitted

October 14, 2021

First Submitted That Met QC Criteria

October 14, 2021

First Posted (Actual)

October 15, 2021

Study Record Updates

Last Update Posted (Estimated)

June 16, 2023

Last Update Submitted That Met QC Criteria

June 15, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10000335
  • 000335-CH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

.The protocol does not have a plan for IPD at this time.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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