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'SPRING'-Study: Subfertility Guidelines: Patient Related Implementation in the Netherlands Among Gynaecologists

Cost Effectiveness of Two Different Strategies to Implement the NVOG Guideline Programme on Subfertility

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00119925
Enrollment
5200
Registered
2005-07-14
Start date
2005-10-31
Completion date
2009-05-31
Last updated
2008-10-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endometriosis, Female Infertility, Male Infertility, Ovarian Hyperstimulation Syndrome, Premature Ovarian Failure

Keywords

infertility, guideline, health care implementation, intervention, gynecology

Brief summary

The purpose of this study is to compare two different strategies to implement the existing Guideline programme on Subfertility, as issued by the Dutch Society of Obstetrics and Gynaecology (NVOG). Therefore, an innovative patient-directed strategy will be compared to a control strategy and effectiveness, costs and feasibility of both strategies will be assessed.

Detailed description

The Dutch Society of Obstetrics and Gynaecology (NVOG) has developed a guideline programme on Subfertility, including 9 guidelines concerning diagnosis and treatment of subfertility and a national IVF protocol. However, guidelines in general do not implement themselves; large gaps consists between best evidence (as described in the guidelines) and practice, resulting in a large variation between professionals. Our study will compare an innovative patient-directed strategy with a (minimal intervention) control strategy, and effectiveness, costs and feasibility of both will be assessed. We eventually aim at the most cost-effective strategy to implement the existing subfertility guideline programme. Please Note: In our protocol, we consider only 'couples' undergoing fertility treatment; therefore, we aim at gathering information from approximately 5200 records, of both male and female participants. When reporting eventually on their treatment, we will consider them only as couples, resulting in reported numbers of approximately 2600 participating couples.

Interventions

BEHAVIORALpatient education

patient leaflets about national guideline contents

BEHAVIORALprofessional audit and feedback (guideline adherence)

feedback on current practice according to quality indicators

BEHAVIORALprofessional education (communication/shared decision making)

educational tools for professionals concerning communication and shared decision making

OTHERinformation tools

tools and checklists to improve information provision

Sponsors

ZonMw: The Netherlands Organisation for Health Research and Development
CollaboratorOTHER
Radboud University Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* each patient, male or female, visiting the OPD for a subfertility related problem or treatment * each patient admitted to the hospital with complications of an infertility treatment

Exclusion criteria

* patients receiving insemination with donor sperm * patients receiving ICSI treatment * patients who are non-Dutch speaking or understand too little Dutch to fill out the questionnaires

Design outcomes

Primary

MeasureTime frame
Extent of guideline adherence after approximately one year (measured by a specific set of guideline-derived indicators, formulated beforehand by the research group)half year after intervention
Costs of both Implementation strategieshalf year after intervention

Secondary

MeasureTime frame
Psychosocial patient characteristics after one year: fear, depression, satisfactionhalf year after intervention

Countries

Netherlands

Contacts

Primary ContactSelma M Mourad, MD
s.mourad@kwazo.umcn.nl+31-24-3610590
Backup ContactRosella PMG Hermens, MSc, PhD
R.hermens@kwazo.umcn.nl+31-24-3613129

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026