FertilityQUESE2NCT02364739
Evaluate Educational Interventions for Increasing Fertility Knowledge and Awareness
A study testing Written information and Written and oral information in people with Fertility, run by Fundació Privada Eugin at 1 site in Spain.
Trial summary
Fertility knowledge and awareness is considered insufficient in women of reproductive age from developed countries. The objective of this study is to evaluate if educational interventions in oocyte donors increase on their level of fertility knowledge and awareness. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fertility
- What is being tested?
- Written information and Written and oral information
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 201 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2014to Jan 2015
- 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 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women candidate to oocyte donation
Who cannot join
- Previous donations cycles at the center
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial to Evaluate Two Educational Interventions for Increasing Fertility Knowledge and Awareness in Oocyte Donors
Fertility knowledge and awareness is considered insufficient in women of reproductive age from developed countries. The objective of this study is to evaluate if educational interventions in oocyte donors increase on their level of fertility knowledge and awareness.
Read the detailed description
Fertility knowledge and awareness is considered insufficient in women of reproductive age from developed countries. The objective of this study is to evaluate if educational interventions in oocyte donors increase on their level of fertility knowledge and awareness through a RCT. The investigators will evaluate the effect of the interventions through a questionnaire filled in at first visit (pre-test) and at the end of the treatment (post-test); the investigators will compare the increase in the total score between groups.
- Conditions
- Fertility
- Being tested
- Written information, Written and oral information
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Written informationOther
Brochure
Written and oral informationOther
Written information consists in a brochure with information about fertility, while oral information consists in a tailored oral explanation about the wrong answers to the pre-test (that is related to the brochure).
| Study group | Role | What they receive |
|---|---|---|
| Written information | Experimental | Written information Receives: Other: Written information |
| Written and oral information | Experimental | Written and oral information Receives: Other: Written and oral information |
| No intervention | No intervention | Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fertility knowledge increase measured as the difference on total score of the questionnaire at post-test
Difference on total score of the questionnaire about fertility knowledge at post-test, that is filled in between 1 and 8 months after the pre-test (i.e. at the end of the donation cycle).
Measured: up to 8 months
Secondary outcomes (1)
Advancement in the reported ideal age for childbearing at post-test
Difference on the reported ideal age for childbearing at post-test, respect to the pre-test
Measured: up to 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2015 (estimated)
- Study startJan 2014
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FertilityStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 201 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundació Privada Eugin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Désirée García, Principal investigator, Fundació Privada Eugin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02364739
- Sponsor's protocol ID
- QUESE2
- Acronym
- QUESE2
- Status last verified
- Feb 2015
- First submitted
- 3 Dec 2013
- Last updated
- 18 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial to Evaluate Two Educational Interventions for Increasing Fertility Knowledge and Awareness in Oocyte Donors
- ClinicalTrials.gov ID
- NCT02364739
- Acronym / sponsor ID
- QUESE2 / QUESE2
- Conditions
- Fertility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- Fundació Privada EuginUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 18 Feb 2015 (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.
Fertility knowledge and awareness is considered insufficient in women of reproductive age from developed countries. The objective of this study is to evaluate if educational interventions in oocyte donors increase on their level of fertility knowledge and awareness.
Detailed description
Fertility knowledge and awareness is considered insufficient in women of reproductive age from developed countries. The objective of this study is to evaluate if educational interventions in oocyte donors increase on their level of fertility knowledge and awareness through a RCT. The investigators will evaluate the effect of the interventions through a questionnaire filled in at first visit (pre-test) and at the end of the treatment (post-test); the investigators will compare the increase in the total score between groups.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Written information | Experimental | Other: Written informationWritten information |
| Written and oral information | Experimental | Other: Written and oral informationWritten and oral information |
| No intervention | No intervention | –Control |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Women candidate to oocyte donation
Key exclusion criteria (1 listed)
- Previous donations cycles at the center
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 |
|---|---|---|
| Written informationBrochure | Other | Written information |
| Written and oral informationWritten information consists in a brochure with information about fertility, while oral information consists in a tailored oral explanation about the wrong answers to the pre-test (that is related to the brochure). | Other | Written and oral information |
Primary outcome
Fertility knowledge increase measured as the difference on total score of the questionnaire at post-test
Time frame: up to 8 months
Difference on total score of the questionnaire about fertility knowledge at post-test, that is filled in between 1 and 8 months after the pre-test (i.e. at the end of the donation cycle).
1 secondary outcome
Advancement in the reported ideal age for childbearing at post-test
Time frame: up to 8 months
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 Feb 2015.
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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.
Désirée García principal investigator
Fundació Privada Eugin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Written information and Written and oral information in people with Fertility, run by Fundació Privada Eugin at 1 site in Spain.
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 1 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 Feb 2015. 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 Spain. 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?
Fertility knowledge increase measured as the difference on total score of the questionnaire at post-test (time frame: up to 8 months). 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 Feb 2015.