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

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

This study is not yet open for patient recruitment.

Sponsors and Collaborators: Radboud University
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by: Radboud University

Purpose

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.
Condition Intervention
Male Infertility
Female Infertility
Ovarian Hyperstimulation Syndrome
Premature Ovarian Failure
Endometriosis
 Behavior: patient education
 Behavior: professional audit and feedback (guideline adherence)
 Behavior: professional education (communication/shared decision making)

MedlinePlus related topics:  Endocrine Diseases;   Endometriosis;   Infertility;   Premature Ovarian Failure;   Reproductive Health

Study Type: Interventional
Study Design: Educational/Counseling/Training, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study

Official Title: Cost Effectiveness of Two Different Strategies to Implement the NVOG Guideline Programme On Subfertility

Further Study Details: 
Primary Outcomes: Extent of guideline adherence after approximately one year (measured by a specific set of guideline-derived indicators, formulated beforehand by the research group); Costs of both Implementation strategies
Secondary Outcomes: Psychosocial patient characteristics after one year: fear, depression, satisfaction
Expected Total Enrollment:  5200

Study start: August 2005;  Expected completion: December 2007
Last follow-up: July 2007;  Data entry closure: July 2007

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.

Eligibility

Ages Eligible for Study:  18 Years   -   80 Years,  Genders Eligible for Study:  Both
Criteria

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

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00119925

Selma M Mourad, MD      +31-24-3610590    s.mourad@kwazo.umcn.nl
Rosella PMG Hermens, MSc, PhD      +31-24-3613129    R.hermens@kwazo.umcn.nl

Netherlands
      Radboud University Nijmegen Medical Centre, Nijmegen,  6500HB,  Netherlands
Jan AM Kremer, MD, PhD  +31-24-3610590 

      Rijnstate Ziekenhuis, ARNHEM,  Netherlands
Alex P Schmoutziguer, MD  +31-24-3610590 

      Canisius Wilhelmina Ziekenhuis, Nijmegen,  Netherlands
Anton Franssen, MD  +31-24-3610590 

      Bernhoven Ziekenhuis, Oss,  Netherlands
Jos Vollebergh, MD  +31-243610590 

      Bernhoven Ziekenhuis, Veghel,  Netherlands
Mirjam van Rozendaal, MD  +31-24-3610590 

      Rivierenland Ziekenhuis, Tiel,  Netherlands
Guido Muijsers, MD  +31-24-3610590 

      st Antonius Ziekenhuis, Nieuwegein,  Netherlands
Jules Schagen van Leeuwen, MD  +31-24-3610590 

      Maxima Medisch Centrum, VELDHOVEN,  Netherlands
Ben W Mol, MD  +31-24-3610590 

      Ziekenhuis Gelderse Vallei, Ede,  Netherlands
Eduard Scheenjes, MD  +31-243610590 

      Streekziekenhuis Zevenaar, Zevenaar,  Netherlands
Vincent Blom, MD  +31-243610590 

      Catharina Ziekenhuis, Eindhoven,  Netherlands
Peter A van Dop, MD, PhD  +31-243610590 

      Jeroen Bosch Ziekenhuis, Den Bosch,  Netherlands
Carl Hamilton, MD  +31-24-3610590 

      Slingeland Ziekenhuis, Doetinchem,  Netherlands
Eveline Tepe, MD  +31-243610590 

      ZBC stichting Geertgen, de Mortel,  Netherlands
Henk Ruis, MD  +31-24-3610590 

      Maasziekenhuis Pantein, Boxmeer,  Netherlands
Ineke Minkhorst, MD  +31-24-3610590 

      Gelre Ziekenhuizen, Apeldoorn,  Netherlands
Laurens j van Dam, MD  +31-24-3610590 

Study chairs or principal investigators

Rosella PMG Hermens, MSc, PhD,  Principal Investigator,  Centre for Quality of Care Research   
Jan AM Kremer, MD, PhD,  Principal Investigator,  Department of Obstetrics and Gynecology, Radboud University Nijmegen Medical Centre   
Didi D Braat, Prof. MD PhD,  Study Chair,  Department of Obstetrics and Gynecology, Radboud University Nijmegen Medical Centre   
Richard PT Grol, Prof. PhD,  Study Chair,  Centre for Quality of Care Research   
E Adang,  Study Director,  Department of Medical Technology Assessment, Radboud University Nijmegen Medical Centre   
J MM van Lith, MD, PhD,  Study Director,  Dutch Society of Obstetrics and Gynecology   
G Zielhuis, Prof PhD,  Study Director,  Department of Epidemiology and Biostatistics, Radboud University Nijmegen Medical Centre   

More Information

Study ID Numbers:  SPRING 2005-01; ZonMw grant no. 945-14-116
Record last reviewed:  July 2005
Last Updated:  July 25, 2005
Record first received:  July 14, 2005
ClinicalTrials.gov Identifier:  NCT00119925
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
ClinicalTrials.gov processed this record on 2005-07-26

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