Unexplained Subfertile Couples With a Good Prognosis.NCT01820039
FertiScreen: an Online Application to Improve the Quality of Fertility Care
A study testing FertiScreen in people with Unexplained Subfertile Couples With a Good Prognosis., run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
Objectives The investigators present an online application to empower and inform patients and improve guideline adherence in unexplained subfertility. Thereby the investigators expect to reduce overtreatment in fertility care with higher quality of care. Read more about this study
- Who is it for?
- Ages 18 to 37 years
- Conditions the study is for
- Unexplained Subfertile Couples With a Good Prognosis.
- What is being tested?
- FertiScreen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 1 siteNetherlands
- Study dates
- Jun 2013to May 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 37 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- couple consulting their general practitioner with subfertility
- women >18 years and <38 years
- one of the partners Dutch speaking
- access to the Internet
- residing in the Netherlands
- unfulfilled childwish for at least 6 months
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Radboud University Nijmegen Medical Centre
Nijmegen, PO Box 9101, 6500 HB
About this study
Objectives The investigators present an online application to empower and inform patients and improve guideline adherence in unexplained subfertility. Thereby the investigators expect to reduce overtreatment in fertility care with higher quality of care.
Methods The investigators conduct a prospective cohort study including couples with a diagnosis of unexplained subfertility. Couples consulting their general practitioner with an unfulfilled child wish will be offered to use FertiScreen. FertiScreen is an online application, in which patients are asked questions about their fertility problem (ie menstrual cycle, age, duration of child wish and the results of the Chlamydia Trachomatis antibody titre and semen analysis). FertiScreen then uses the validated prediction model of Hunault to calculate couples' chance of natural conception during the next twelve months. In addition, patients can find links to extra information concerning subfertility. Couples can then initiate an online consultation with their general practitioner and a gynaecologist, in order to discuss their results and prognosis. When the calculated prognosis of spontaneous conception within one year is >30%, tailored expectant management for 6-12 months will be advised, as no benefit can be expected from fertility treatment.
Read more
Questionnaires will be sent to patients as well as to their caregivers (general practitioner, gynaecologist). These questionnaires will focus on the use of FertiScreen (System Usability Scale) and the different domains of quality of care (effectiveness, cost-effectiveness, safety, patient-centredness). For the latter, the investigators use the Hospital Anxiety and Depression Scale and the Patient Centredness Questionnaire for Infertility.
In order to be able to draw conclusions, the investigators will conduct a baseline measurement among couples with unexplained subfertility who have been referred to a fertility clinic. Their data will be abstracted from their medical records and they will receive the aforementioned questionnaires as well (except for the System Usability Scale).
The investigators will recruit couples presenting to general practitioners in the Nijmegen area (which for second line treatment consists of one general hospital and one academic hospital). To detect an increase in guideline adherence of the current 60% to 75% with a power of 80% (P<0,05), the investigators need to include 152 couples in the before as well as in the after measurement.
- Being tested
- FertiScreen
- Keywords
- e-health intervention, infertility, primary care, referral rate
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FertiScreenOther
FertiScreen is an online application to assess whether referral is necessary or expectant management is indicated.
| Study group | Role | What they receive |
|---|---|---|
| FertiScreen | Experimental | all patients between 18 and 38 years, consulting their general practitioner for infertility will be asked to use FertiScreen. Receives: Other: FertiScreen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of the application: adherence to tailored expectant management
The adherence to tailored expectant management: measured by the percentage of patients with unexplained infertility with a good prognosis of spontaneous conception within one year (>30%) with tailored expectant management.
Measured: Two years
Secondary outcomes (1)
experiences with FertiScreen
Among the patients the focus will be on ease of use, speed of use, sense of privacy, the extent to which the experience meet previous expectations and the recognisability of the given advise. Among health care providers, the evaluation will focus on the experienced changes in the daily care.
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2013 (estimated)
- Study startJun 2013
- Primary completionMay 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unexplained Subfertile Couples With a Good Prognosis.Studies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 152 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jan AM Kremer, MD, PhD, Study director, IQ Healthcare, UMC St Radboud, Nijmegen, The Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01820039
- Sponsor's protocol ID
- FertiScreen
- Status last verified
- Mar 2013
- First submitted
- 14 Mar 2013
- Last updated
- 16 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FertiScreen: an Online Application to Improve the Quality of Fertility Care
- ClinicalTrials.gov ID
- NCT01820039
- Acronym / sponsor ID
- FertiScreen
- Keywords
- e-health intervention, infertility, primary care, referral rate
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 152 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- May 2015 (estimated)
- First posted
- 28 Mar 2013 (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.
Objectives The investigators present an online application to empower and inform patients and improve guideline adherence in unexplained subfertility. Thereby the investigators expect to reduce overtreatment in fertility care with higher quality of care.
Methods The investigators conduct a prospective cohort study including couples with a diagnosis of unexplained subfertility. Couples consulting their general practitioner with an unfulfilled child wish will be offered to use FertiScreen. FertiScreen is an online application, in which patients are asked questions about their fertility problem (ie menstrual cycle, age, duration of child wish and the results of the Chlamydia Trachomatis antibody titre and semen analysis). FertiScreen then uses the validated prediction model of Hunault to calculate couples' chance of natural conception during the next twelve months. In addition, patients can find links to extra information concerning subfertility. Couples can then initiate an online consultation with their general practitioner and a gynaecologist, in order to discuss their results and prognosis. When the calculated prognosis of spontaneous conception within one year is >30%, tailored expectant management for 6-12 months will be advised, as no benefit can be expected from fertility treatment.
Questionnaires will be sent to patients as well as to their caregivers (general practitioner, gynaecologist). These questionnaires will focus on the use of FertiScreen (System Usability Scale) and the different domains of quality of care (effectiveness, cost-effectiveness, safety, patient-centredness). For the latter, the investigators use the Hospital Anxiety and Depression Scale and the Patient Centredness Questionnaire for Infertility.
In order to be able to draw conclusions, the investigators will conduct a baseline measurement among couples with unexplained subfertility who have been referred to a fertility clinic. Their data will be abstracted from their medical records and they will receive the aforementioned questionnaires as well (except for the System Usability Scale).
The investigators will recruit couples presenting to general practitioners in the Nijmegen area (which for second line treatment consists of one general hospital and one academic hospital). To detect an increase in guideline adherence of the current 60% to 75% with a power of 80% (P<0,05), the investigators need to include 152 couples in the before as well as in the after measurement.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FertiScreen | Experimental | Other: FertiScreenall patients between 18 and 38 years, consulting their general practitioner for infertility will be asked to use FertiScreen. |
Who may qualify
- Ages
- 18 to 37 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- couple consulting their general practitioner with subfertility
- women >18 years and <38 years
- one of the partners Dutch speaking
- access to the Internet
- residing in the Netherlands
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| FertiScreenFertiScreen is an online application to assess whether referral is necessary or expectant management is indicated. | Other | FertiScreen |
Primary outcome
Effectiveness of the application: adherence to tailored expectant management
Time frame: Two years
The adherence to tailored expectant management: measured by the percentage of patients with unexplained infertility with a good prognosis of spontaneous conception within one year (>30%) with tailored expectant management.
1 secondary outcome
experiences with FertiScreen
Time frame: two years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2013.
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.
Jan AM Kremer, MD, PhD study director
IQ Healthcare, UMC St Radboud, Nijmegen, The Netherlands
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FertiScreen in people with Unexplained Subfertile Couples With a Good Prognosis., run by Radboud University Medical Center at 1 site in Netherlands.
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 6 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 16 Dec 2013. 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 Netherlands. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Helga van der Pluijm-Schouten, MD (+31243617769, H.Schouten@obgyn.umcn.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of the application: adherence to tailored expectant management (time frame: Two 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 16 Dec 2013.