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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00119925
Other study ID # SPRING 2005-01
Secondary ID ZonMw grant no.
Status Recruiting
Phase N/A
First received July 5, 2005
Last updated October 28, 2008
Start date October 2005
Est. completion date May 2009

Study information

Verified date October 2008
Source Radboud University
Contact Selma M Mourad, MD
Phone +31-24-3610590
Email s.mourad@kwazo.umcn.nl
Is FDA regulated No
Health authority Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 5200
Est. completion date May 2009
Est. primary completion date February 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver)


Intervention

Behavioral:
patient education
patient leaflets about national guideline contents
professional audit and feedback (guideline adherence)
feedback on current practice according to quality indicators
professional education (communication/shared decision making)
educational tools for professionals concerning communication and shared decision making
Other:
information tools
tools and checklists to improve information provision

Locations

Country Name City State
Netherlands 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 Canisius Wilhelmina Ziekenhuis Nijmegen
Netherlands Radboud University Nijmegen Medical Centre Nijmegen
Netherlands Bernhoven Ziekenhuis Oss
Netherlands Rivierenland Ziekenhuis Tiel
Netherlands Bernhoven Ziekenhuis Veghel
Netherlands Maxima Medisch Centrum Veldhoven
Netherlands Streekziekenhuis Zevenaar Zevenaar

Sponsors (2)

Lead Sponsor Collaborator
Radboud University ZonMw: The Netherlands Organisation for Health Research and Development

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Primary Costs of both Implementation strategies half year after intervention No
Secondary Psychosocial patient characteristics after one year: fear, depression, satisfaction half year after intervention No
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