Primary Ciliary Dyskinesia (PCD)REPRoDUCENCT07531277
Developing Resource Interventions for Healthcare Professionals and Patients to Improve Knowledge About Fertility in Primary Ciliary Dyskinesia
A study testing Online educational resource and Toolkit for healthcare professionals in people with Primary Ciliary Dyskinesia (PCD) and Fertility, run by University of Southampton.
Trial summary
This project will involve working with people with PCD and medical professionals to develop resources that will help patients and the people providing their care to better understand fertility and pregnancy safety in people with this condition. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Ciliary Dyskinesia (PCD), Fertility, Pregnancy
- What is being tested?
- Online educational resource and Toolkit for healthcare professionals
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2026to 31 Mar 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 years or older
- 'Highly likely' or confirmed diagnosis of Primary Ciliary dyskinesia, or being a healthcare professional, or representative from a stakeholder group e.g. patient led charity
- Able to understand and willing to sign the informed participant consent prior to participation
Who cannot join
- Unwilling to participate in the study
- Not meeting inclusion criteria
- Unable to understand or unwilling to sign the informed participant consent prior to participation
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Ying Cheong contact
About this study
Official title: REproductive Health in PRimary Ciliary Dyskinesia: Developing User-informed Clinical and Educational Resources (REPRoDUCE)
This project will involve working with people with PCD and medical professionals to develop resources that will help patients and the people providing their care to better understand fertility and pregnancy safety in people with this condition.
Read the detailed description
The study investigators will co-develop an online educational animation and text resource for patients and the public about PCD and fertility and pregnancy.
Development of patient resource:
The study investigators will conduct workshops with a group of approximately ten people including additional PPI representatives (adults with lived experience of PCD), representatives from PCD Support UK and medical professionals specialising in PCD. In stage 1 of the resource development, the study investigators will conduct an online workshop to identify priorities for information for inclusion in the resource. In stage 2 the study investigators will create a resource prototype based on the information gained in stage 1. In stage 3 the study investigators will conduct and record 1:1 online think aloud interviews to capture real-time reactions and gain evaluation of the resource prototype to identify areas for improvement. In stage 4, the study investigators will make further resource modifications. In stage 5 the intervention will be tested in a sample of men and women with PCD (n=10). The study investigators will then conduct an online quiz to measure pre- and post- resource use knowledge about PCD, fertility and pregnancy, and collect suggestions for improvement via a survey form. Feedback from stage 5 will be incorporated into the final resource prior to dissemination.
The resource will be translated into non-English languages spoken in the UK to aid inclusion of a wider audience.
Co-development of toolkit for medical professionals:
The study investigators will co-develop an online educational toolkit for medical professionals about fertility and pregnancy in patients with PCD. The study investigators will utilise the same group of approximately ten people including PPI representatives, representatives from PCD Support UK and medical professionals specialising in PCD as above. The study investigators will follow the above stages 1-4 for development of the toolkit. In stage 5, the study investigators will test the intervention in a sample of non-PCD specialists (n=10). During this stage an online quiz will be conducted to measure pre- and post- toolkit use knowledge about PCD, fertility and pregnancy, and collect suggestions for improvement via a survey form. Feedback from stage 5 will be incorporated into the final resource prior to dissemination.
- Being tested
- Online educational resource, Toolkit for healthcare professionals
- Medical subject headings
- Ciliary Motility Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online educational resourceOther
Co-developed educational resource for patients
Toolkit for healthcare professionalsOther
co-developed online educational toolkit for healthcare professionals
| Study group | Role | What they receive |
|---|---|---|
| Use of educational resource for patients | Experimental | Online resource use by adults with PCD Receives: Other: Online educational resource |
| Use of educational resource for healthcare professionals | Experimental | Use of online toolkit by healthcare professionals Receives: Other: Toolkit for healthcare professionals |
What is being measured
The primary outcome is the main question the study is designed to answer.
A resource for patients and a toolkit for medical professionals
- Development of a resource for patients and toolkit for healthcare professionals
- Qualitative and quantitive participant data on the acceptability and usefulness of above resources.
Measured: Duration of study (up to 3 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2026
- Study start1 Apr 2026 (estimated)
- Primary completion31 Mar 2029 (estimated)
- Study completion31 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Ciliary Dyskinesia (PCD)Studies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southampton
- Sponsor type
- University, hospital or other
- Collaborators
- University of Cardiff, University Hospital Southampton NHS Foundation Trust
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07531277
- Sponsor's protocol ID
- 107544
- Acronym
- REPRoDUCE
- Status last verified
- Mar 2026
- First submitted
- 24 Mar 2026
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REproductive Health in PRimary Ciliary Dyskinesia: Developing User-informed Clinical and Educational Resources (REPRoDUCE)
- ClinicalTrials.gov ID
- NCT07531277
- Acronym / sponsor ID
- REPRoDUCE / 107544
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of SouthamptonUniversity, hospital or other
- Collaborators
- University of Cardiff, University Hospital Southampton NHS Foundation Trust
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 31 Mar 2029 (estimated)
- Study completion
- 31 Mar 2029 (estimated)
- First posted
- 15 Apr 2026 (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.
This project will involve working with people with PCD and medical professionals to develop resources that will help patients and the people providing their care to better understand fertility and pregnancy safety in people with this condition.
Detailed description
The study investigators will co-develop an online educational animation and text resource for patients and the public about PCD and fertility and pregnancy.
Development of patient resource:
The study investigators will conduct workshops with a group of approximately ten people including additional PPI representatives (adults with lived experience of PCD), representatives from PCD Support UK and medical professionals specialising in PCD. In stage 1 of the resource development, the study investigators will conduct an online workshop to identify priorities for information for inclusion in the resource. In stage 2 the study investigators will create a resource prototype based on the information gained in stage 1. In stage 3 the study investigators will conduct and record 1:1 online think aloud interviews to capture real-time reactions and gain evaluation of the resource prototype to identify areas for improvement. In stage 4, the study investigators will make further resource modifications. In stage 5 the intervention will be tested in a sample of men and women with PCD (n=10). The study investigators will then conduct an online quiz to measure pre- and post- resource use knowledge about PCD, fertility and pregnancy, and collect suggestions for improvement via a survey form. Feedback from stage 5 will be incorporated into the final resource prior to dissemination.
The resource will be translated into non-English languages spoken in the UK to aid inclusion of a wider audience.
Co-development of toolkit for medical professionals:
The study investigators will co-develop an online educational toolkit for medical professionals about fertility and pregnancy in patients with PCD. The study investigators will utilise the same group of approximately ten people including PPI representatives, representatives from PCD Support UK and medical professionals specialising in PCD as above. The study investigators will follow the above stages 1-4 for development of the toolkit. In stage 5, the study investigators will test the intervention in a sample of non-PCD specialists (n=10). During this stage an online quiz will be conducted to measure pre- and post- toolkit use knowledge about PCD, fertility and pregnancy, and collect suggestions for improvement via a survey form. Feedback from stage 5 will be incorporated into the final resource prior to dissemination.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Use of educational resource for patients | Experimental | Other: Online educational resourceOnline resource use by adults with PCD |
| Use of educational resource for healthcare professionals | Experimental | Other: Toolkit for healthcare professionalsUse of online toolkit by healthcare professionals |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged 18 years or older
- 'Highly likely' or confirmed diagnosis of Primary Ciliary dyskinesia, or being a healthcare professional, or representative from a stakeholder group e.g. patient led charity
- Able to understand and willing to sign the informed participant consent prior to participation
Key exclusion criteria (3 listed)
- Unwilling to participate in the study
- Not meeting inclusion criteria
- Unable to understand or unwilling to sign the informed participant consent prior to participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online educational resourceCo-developed educational resource for patients | Other | Use of educational resource for patients |
| Toolkit for healthcare professionalsco-developed online educational toolkit for healthcare professionals | Other | Use of educational resource for healthcare professionals |
Primary outcome
A resource for patients and a toolkit for medical professionals
Time frame: Duration of study (up to 3 years)
1. Development of a resource for patients and toolkit for healthcare professionals 2. Qualitative and quantitive participant data on the acceptability and usefulness of above resources.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
- Individual participant dataSharing planned: Undecided
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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.
Ying Cheong contact
Questions about this trial
What is this clinical trial studying?
A study testing Online educational resource and Toolkit for healthcare professionals in people with Primary Ciliary Dyskinesia (PCD) and Fertility, run by University of Southampton.
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 3 inclusion and 3 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: opening soon, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lydia Newman (+44 23 8120 6033, Lydia.newman@soton.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A resource for patients and a toolkit for medical professionals (time frame: Duration of study (up to 3 years)). 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 15 Apr 2026.