Unexplained Subfertile Couples With a Good Prognosis. Clinical Trial
Official title:
FertiScreen: an Online Application to Improve the Quality of Fertility Care
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.
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research