Unexplained Subfertile Couples With a Good Prognosis. Clinical Trial
Official title:
FertiScreen: an Online Application to Improve the Quality of Fertility Care
| NCT number | NCT01820039 |
| Other study ID # | FertiScreen |
| Secondary ID | |
| Status | Recruiting |
| Phase | N/A |
| First received | March 14, 2013 |
| Last updated | December 13, 2013 |
| Start date | June 2013 |
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.
| Status | Recruiting |
| Enrollment | 152 |
| Est. completion date | |
| Est. primary completion date | May 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 37 Years |
| Eligibility |
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 |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research
| Country | Name | City | State |
|---|---|---|---|
| Netherlands | Radboud University Nijmegen Medical Centre | Nijmegen | PO Box 9101 |
| Lead Sponsor | Collaborator |
|---|---|
| Radboud University |
Netherlands,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | effects on quality of care | Efficiency: economic analysis (number of consultations in the second line and the number of diagnostic tests carried out. Safety: we will measure complaints of anxiety and depression and quality of life at a patient level. Future implications: we will give advises for implementation strategy to optimize use of FertiScreen. |
two years | No |
| Primary | 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 | No |
| Secondary | 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 | No |