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

Not Applicable

• Conditions: Male Infertility; Female Infertility; Ovarian Hyperstimulation Syndrome; Premature Ovarian Failure; Endometriosis

• Registration Number: NCT00119925
• Lead Sponsor: Radboud University Medical Center

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.

Study Timeline

• Study First Submitted: 2005-07-05
• Study First Submitted QC: 2005-07-07
• Study First Posted: 2005-07-14
• Study Start: 2005-10
• Status Verified: 2008-10
• Last Update Submitted: 2008-10-28
• Last Update Posted: 2008-10-29
• Primary Completion: 2009-02
• Study Completion: 2009-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 5200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 strategies	half year after intervention

Secondary Outcome Measures

Name	Time	Method
Psychosocial patient characteristics after one year: fear, depression, satisfaction	half year after intervention

Trial Locations

Locations (15)

Gelre Ziekenhuizen; 🇳🇱 Apeldoorn, Netherlands

Rijnstate Ziekenhuis; 🇳🇱 Arnhem, Netherlands

Maasziekenhuis Pantein; 🇳🇱 Boxmeer, Netherlands

ZBC stichting Geertgen; 🇳🇱 de Mortel, Netherlands

Jeroen Bosch Ziekenhuis; 🇳🇱 den Bosch, Netherlands

Slingeland Ziekenhuis; 🇳🇱 Doetinchem, Netherlands

Ziekenhuis Gelderse Vallei; 🇳🇱 Ede, Netherlands

Catharina Ziekenhuis; 🇳🇱 Eindhoven, Netherlands

st Antonius Ziekenhuis; 🇳🇱 Nieuwegein, Netherlands

Radboud University Nijmegen Medical Centre; 🇳🇱 Nijmegen, Netherlands

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