english: infertility, tailored expectant management, prognostic models nederlands: subfertiliteit, afwachtend beleid, prognostische modellen
Conditions
Interventions
In this cluster randomized trial, 25 clinics and their allied general practitioner units are randomized between the intervention and control group. In the intervention group a multifaceted implementat
2. Professionals-level: Audit and feedback of pre-randomisation data collection, educational outreach visits, communication training and a digital version of the prognostic model as an application for
3. Organisation-level: Local protocol and a local consensus processes.
The effect of the strategy will be evaluated by a pre- and post-randomization data collection and a process evaluation.
Sponsors
Academic Medical Centre Amsterdam. Department of Obstetrics and Gynaecology
Eligibility
Inclusion criteria
Inclusion criteria: 1. Couples with unexplained subfertility or mild subfertility; 2. Age between 18 and 38 years; 3. Referred by a general practitioner or on own initiative; 4. No previous fertility treatment in medical history; 5. A prognosis of more than 30 percent chance of natural conception within one year based on the prediction model of Hunault.
Exclusion criteria
Exclusion criteria: 1. Age 38 years or older; 2. Fertility treatment in medical history; 3. Referred by another gynaecologist, fertility doctor; 4. Anovulation: Menstrual cycle of less than 24 days or more than 35 days / no menses for over 6 months; 5. Two-sided tubal pathology. Diagnosed by a HCG or laparoscopy; 6. Severe male subfertility. VCM< 3 million (< 3 x 10^6); 7. Couples with a prognosis of less than 30 percent chance of natural conception within one year based on the prediction model of Hunault.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is the effect of the strategy on the adherence to tailored expectant management. Measured by the difference in the percentage of couples with unexplained subfertility, with a good prognosis of spontaneous conception within one year (>30%), with tailored expectant management in the year before the intervention and during the intervention period. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Treatment outcome related measures like ongoing pregnancy and multiple pregnancy rates, time to pregnancy; 2. Process related measures like percentage transition of patients to another fertility centre and patient related outcome measures like quality of life (FertiQoL) and general experiences with fertility care such as information provision, respect for patients’ values and accessibility of care (Patient Centeredness Questionnaire Infertility); 3. A process related evaluation will assess the intensity of exposure to all the different strategy elements per patient, per clinic and per region. In addition, the feasibility and usefulness of all strategy elements will be evaluated; 4. We will investigate the cost-effectiveness of the multifaceted strategy to implement tailored expectant management. This economic evaluation compares a multifaceted implementation strategy to usual care and is done from a healthcare perspective. | — |
Contacts
Public ContactF.A.M. Kersten
Postbus 9101
Outcome results
None listed