Vergelijkend onderzoek naar het effect van een meervoudige strategie op het gebruik van voorspellende modellen en afwachtend beleid bij paren met vruchtbaarheidsproblemen.
- Conditions
- english: infertility, tailored expectant management, prognostic modelsnederlands: subfertiliteit, afwachtend beleid, prognostische modellen
- Registration Number
- NL-OMON25539
- Lead Sponsor
- Academic Medical Centre Amsterdam. Department of Obstetrics and Gynaecology
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 900
Inclusion Criteria
1. Couples with unexplained subfertility or mild subfertility;
2. Age between 18 and 38 years;
Exclusion Criteria
1. Age 38 years or older;
2. Fertility treatment in medical history;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 1. Treatment outcome related measures like ongoing pregnancy and multiple pregnancy rates, time to pregnancy;<br /><br>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);<br /><br>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;<br /><br>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.