FertiScreen: an Online Application to Improve the Quality of Fertility Care

Study Overview
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Brief Summary
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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.

Official Title
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FertiScreen: an Online Application to Improve the Quality of Fertility Care

Conditions
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Unexplained Subfertile Couples With a Good Prognosis.

Intervention / Treatment
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* Other: FertiScreen


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 37 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FertiScreen<br>all patients between 18 and 38 years, consulting their general practitioner for infertility will be asked to use FertiScreen. | Other: FertiScreen<br>* FertiScreen is an online application to assess whether referral is necessary or expectant management is indicated.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | two years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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e-health intervention, infertility, primary care, referral rate