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

NCT01820039 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 152

Last updated 2013-12-16

No results posted yet for this study

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.

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.

Conditions

  • Unexplained Subfertile Couples With a Good Prognosis.

Interventions

OTHER

FertiScreen

FertiScreen is an online application to assess whether referral is necessary or expectant management is indicated.

Sponsors & Collaborators

  • Radboud University Medical Center

    lead OTHER

Principal Investigators

  • Jan AM Kremer, MD, PhD · IQ Healthcare, UMC St Radboud, Nijmegen, The Netherlands

Study Design

Allocation
NA
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
37 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2015-05-31

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01820039 on ClinicalTrials.gov