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

NCT05078892 | Completed

• 2 other identifiers: 10000335000335-CH
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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....

Conditions

Fertility Perservation; Fertility

Keywords

Phenotyping; attitudes of individuals with TS; survey of adolescents and young adults; Natural History

Outcome Measures

Primary Outcomes (2)

• SURVEY CONTENT

  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

  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 Outcomes (2)

• RESPONSE SCORES

  Baseline

• RESPONSE SCORES

  Baseline

Study Arms (3)

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

Eligibility Criteria

• Age: 12 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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).

You may qualify if:

• In order to be eligible to participate in this study, an individual must meet all of the following criteria:
• Stated willingness to comply with all study procedures and availability for the duration ofthe study
• Adolescents and young adults ages 12 to 25 years who self- identify as having Turnersyndrome
• Individuals who self-identity as parents/guardians of adolescents and young adults ages12 to 25 years with Turner syndrome

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

National Institute of Child Health and Human Development (NICHD)

Bethesda, Maryland, 20892, United States

Location

Study Officials

• Veronica Gomez-Lobo, M.D.

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2021
• First Posted: October 15, 2021
• Study Start: August 25, 2022
• Primary Completion: June 12, 2023
• Study Completion: June 12, 2023
• Last Updated: June 18, 2023

Record last verified: 2023-06

Locations

US (1)