Fertility; Decision to Get PregnantCFPANCT02813993
Couples Fertility and Pregnancy Awareness
A study testing Health educational video in people with Fertility; Decision to Get Pregnant, run by Universidade do Porto at 1 site in Portugal.
Trial summary
Recent evidence has shown that young people that want to have children have low fertility knowledge. This study evaluates the efficacy of a video intervention on fertility knowledge, on changes in lifestyle and on the decision to start to get pregnant. Read more about this study
- Who is it for?
- Ages 24 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Fertility; Decision to Get Pregnant
- What is being tested?
- Health educational video
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 244 participants
- Where
- 1 sitePortugal
- Study dates
- Oct 2016to Oct 2020
- Phase
- Interventional
- 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 24 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female member of the couples has between 24 to 40 years
- Childless couples trying to conceive or couples who desired to have children in the next 3 years
- Relationship length minimum of one year
Who cannot join
- Couples that already had achieved a successful pregnancy
- Couples with children
Trial locations and contacts
1 site in 1 country.
Portugal1 site
University of Porto, Faculty of Psychology and Educational and Education Sciences
Porto, 4200-193
About this study
Recent evidence has shown that young people that want to have children have low fertility knowledge. This study evaluates the efficacy of a video intervention on fertility knowledge, on changes in lifestyle and on the decision to start to get pregnant.
Read the detailed description
This study will compare the efficacy of a video intervention versus control (no video) in couples that intend to have children in the next three years. The couples will be randomized to the two groups. The video contains information concerning age-related fertility decline, fertility risk factors, the success of infertility treatments, and emotional consequences of childlessness.
- Conditions
- Fertility; Decision to Get Pregnant
- Being tested
- Health educational video
- Keywords
- infertility, fertility awareness, preconceptional care, health interventions, couples
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health educational videoOther
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | A five-minute video concerning age-related fertility decline, fertility risk factors, success of infertility treatments and emotional consequences of childlessness Receives: Other: Health educational video |
| Control | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Fertility knowledge
This measure assesses fertility knowledge by asking questions on the probability of conception and fertility treatment success rates, infertility definition and infertility risk factors
Measured: T0 - before the intervention; T1 - one month later; T2 - six months later; T3 - one year later
Secondary outcomes (2)
Change in number of months planned to get pregnant/pregnancy
This question measures the number of months estimated by participants until they get pregnant or pregnancy
Measured: T0 - before the intervention; T1 - one month later; T2 - six months later; T3 - one year later
Change in intention and adoption of fertility-optimizing behaviors
These questions assessed the intentions to adopt and the effective adoption of fertility-optimizing behaviors
Measured: T0 - before the intervention; T1 - one month later; T2 - six months later; T3 - one year later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2016 (estimated)
- Study startOct 2016
- Primary completionOct 2020
- Study completionOct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fertility; Decision to Get PregnantStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 244 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade do Porto
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação para a Ciência e a Tecnologia
- Responsible party
- Sponsor
- Investigators
- Juliana Pedro, MSc, Principal investigator, Universidade do Porto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02813993
- Sponsor's protocol ID
- FPCEUP/RH2
- Other IDs
- SFRH/BD/103234/2014
- Acronym
- CFPA
- Status last verified
- Mar 2020
- First submitted
- 17 Jun 2016
- Last updated
- 11 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Couples Fertility and Pregnancy Awareness
- ClinicalTrials.gov ID
- NCT02813993
- Acronym / sponsor ID
- CFPA / FPCEUP/RH2
- Conditions
- Fertility; Decision to Get Pregnant
- Keywords
- infertility, fertility awareness, preconceptional care, health interventions, couples
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 244 participants (actual)
- Lead sponsor
- Universidade do PortoUniversity, hospital or other
- Collaborators
- Fundação para a Ciência e a Tecnologia
- Study start
- Oct 2016
- Primary completion
- Oct 2020 (actual)
- Study completion
- Oct 2020 (actual)
- First posted
- 27 Jun 2016 (estimated)
- 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.
Recent evidence has shown that young people that want to have children have low fertility knowledge. This study evaluates the efficacy of a video intervention on fertility knowledge, on changes in lifestyle and on the decision to start to get pregnant.
Detailed description
This study will compare the efficacy of a video intervention versus control (no video) in couples that intend to have children in the next three years. The couples will be randomized to the two groups. The video contains information concerning age-related fertility decline, fertility risk factors, the success of infertility treatments, and emotional consequences of childlessness.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Health educational videoA five-minute video concerning age-related fertility decline, fertility risk factors, success of infertility treatments and emotional consequences of childlessness |
| Control | No intervention | –No intervention |
Who may qualify
- Ages
- 24 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Female member of the couples has between 24 to 40 years
- Childless couples trying to conceive or couples who desired to have children in the next 3 years
- Relationship length minimum of one year
Key exclusion criteria (2 listed)
- Couples that already had achieved a successful pregnancy
- Couples with children
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 |
|---|---|---|
| Health educational video | Other | Intervention Group |
Primary outcome
Change in Fertility knowledge
Time frame: T0 - before the intervention; T1 - one month later; T2 - six months later; T3 - one year later
This measure assesses fertility knowledge by asking questions on the probability of conception and fertility treatment success rates, infertility definition and infertility risk factors
2 secondary outcomes
Change in number of months planned to get pregnant/pregnancy
Time frame: T0 - before the intervention; T1 - one month later; T2 - six months later; T3 - one year later
Change in intention and adoption of fertility-optimizing behaviors
Time frame: T0 - before the intervention; T1 - one month later; T2 - six months later; T3 - one year later
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 11 Jan 2021.
- Individual participant dataSharing planned: Undecided
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.
Juliana Pedro, MSc principal investigator
Universidade do Porto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health educational video in people with Fertility; Decision to Get Pregnant, run by Universidade do Porto at 1 site in Portugal.
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 2 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 11 Jan 2021. 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 Portugal. 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?
Change in Fertility knowledge (time frame: T0 - before the intervention; T1 - one month later; T2 - six months later; T3 - one year later). 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 11 Jan 2021.