Fertility PerservationNCT05078892
Fertility Attitudes of Adolescents and Young Adults With Turner Syndrome and Their Parents/Guardians (The Fertility ConcepTS Study)
An observational study of Fertility Perservation and Fertility, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Fertility Perservation, Fertility
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Aug 2022to 12 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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).
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute of Child Health and Human Development (NICHD)
Bethesda, Maryland, 20892
About this study
Background:
Turner syndrome (TS) is caused by the partial or complete absence of one of the two X
Read more
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....
Read the 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:
- 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.
- 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:
- 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.
- 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
- Conditions
- Fertility Perservation, Fertility
- Keywords
- Phenotyping, attitudes of individuals with TS, survey of adolescents and young adults, Natural History
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: Baseline
Secondary outcomes (2)
RESPONSE SCORES
Differences in responses between AYA with TS and their parents to the survey content
Measured: Baseline
RESPONSE SCORES
Differences in responses between adolescents aged 12-17 years and young adults aged 18-25 years with TS regarding survey content
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2021
- Study start25 Aug 2022
- Primary completion12 Jun 2023
- Study completion12 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fertility PerservationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Veronica Gomez-Lobo, M.D., Principal investigator, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05078892
- Sponsor's protocol ID
- 10000335
- Other IDs
- 000335-CH
- Status last verified
- Jun 2023
- First submitted
- 14 Oct 2021
- Last updated
- 18 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: .The protocol does not have a plan for IPD at this time.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fertility Attitudes of Adolescents and Young Adults With Turner Syndrome and Their Parents/Guardians (The Fertility ConcepTS Study)
- ClinicalTrials.gov ID
- NCT05078892
- Acronym / sponsor ID
- 10000335
- Conditions
- Fertility Perservation, Fertility
- Keywords
- Phenotyping, attitudes of individuals with TS, survey of adolescents and young adults, Natural History
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)US National Institutes of Health
- Study start
- 25 Aug 2022 (actual)
- Primary completion
- 12 Jun 2023 (actual)
- Study completion
- 12 Jun 2023 (actual)
- First posted
- 15 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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....
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:
- 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.
- 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:
- 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.
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 12 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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).
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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
2 secondary outcomes
RESPONSE SCORES
Time frame: Baseline
RESPONSE SCORES
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2023.
- Individual participant dataSharing planned: Undecided. .The protocol does not have a plan for IPD at this time.
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Enrolling by invitation
Survey of Patients Who Received Fertility Preservation Counseling and Underwent Testicular Tissue Cryopreservation Prior to Gonadotoxic Treatment During Childhood or Peripuberty
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Veronica Gomez-Lobo, M.D. principal investigator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fertility Perservation and Fertility, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SURVEY CONTENT (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2023.