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Male InfertilityNCT00119925

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

A study testing patient education, professional audit and feedback (guideline adherence) and professional education (communication/shared decision making) in people with Male Infertility and Female Infertility, run by Radboud University Medical Center at 16 sites in Netherlands.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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). Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
patient education, professional audit and feedback (guideline adherence) and professional education (communication/shared decision making)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5,200 participants
Where
16 sitesNetherlands
Study dates
Oct 2005to May 2009
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

16 sites in 1 country.

Selma M Mourad, MD contact

+31-24-3610590

s.mourad@kwazo.umcn.nl

Rosella PMG Hermens, MSc, PhD contact

+31-24-3613129

R.hermens@kwazo.umcn.nl

16 sites in 1 country

Netherlands16 sites, 16 recruiting

  • Jeroen Bosch Ziekenhuis

    's-Hertogenbosch

    Carl Hamilton, MD, +31-24-3610590

    Recruiting

  • Gelre Ziekenhuizen

    Apeldoorn

    Laurens j van Dam, MD, +31-24-3610590

    Recruiting

  • Rijnstate Ziekenhuis

    Arnhem

    Alex P Schmoutziguer, MD, +31-24-3610590

    Recruiting

  • Maasziekenhuis Pantein

    Boxmeer

    Ineke Minkhorst, MD, +31-24-3610590

    Recruiting

  • ZBC stichting Geertgen

    De Mortel

    Henk Ruis, MD, +31-24-3610590

    Recruiting

  • Slingeland Ziekenhuis

    Doetinchem

    Eveline Tepe, MD, +31-243610590

    Recruiting

  • Ziekenhuis Gelderse Vallei

    Ede

    Eduard Scheenjes, MD, +31-243610590

    Recruiting

  • Catharina Ziekenhuis

    Eindhoven

    Peter A van Dop, MD, PhD, +31-243610590

    Recruiting

  • st Antonius Ziekenhuis

    Nieuwegein

    Jules Schagen van Leeuwen, MD, +31-24-3610590

    Recruiting

  • Radboud University Nijmegen Medical Centre

    Nijmegen, 6500HB

    Jan AM Kremer, MD, PhD, +31-24-3610590

    Recruiting

  • Canisius Wilhelmina Ziekenhuis

    Nijmegen

    Anton Franssen, MD, +31-24-3610590

    Recruiting

  • Bernhoven Ziekenhuis

    Oss

    Jos Vollebergh, MD, +31-243610590

    Recruiting

  • Rivierenland Ziekenhuis

    Tiel

    Guido Muijsers, MD, +31-24-3610590

    Recruiting

  • Bernhoven Ziekenhuis

    Veghel

    Mirjam van Rozendaal, MD, +31-24-3610590

    Recruiting

  • Maxima Medisch Centrum

    Veldhoven

    Ben W Mol, MD, +31-24-3610590

    Recruiting

  • Streekziekenhuis Zevenaar

    Zevenaar

    Vincent Blom, MD, +31-243610590

    Recruiting

Other trials in Netherlands

About this study

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

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.

Read the 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.

Being tested
patient education, professional audit and feedback (guideline adherence), professional education (communication/shared decision making), information tools
Keywords
infertility, guideline, health care implementation, intervention, gynecology
Medical subject headings
Infertility, Male, Infertility, Female, Ovarian Hyperstimulation Syndrome, Primary Ovarian Insufficiency, Endometriosis, Infertility

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • patient educationBehavioural

    patient leaflets about national guideline contents

  • professional audit and feedback (guideline adherence)Behavioural

    feedback on current practice according to quality indicators

  • professional education (communication/shared decision making)Behavioural

    educational tools for professionals concerning communication and shared decision making

  • information toolsOther

    tools and checklists to improve information provision

Study groups in NCT00119925
Study groupRoleWhat they receive
minimal interventionActive comparatorprofessional audit and feedback on current practice
Receives: Behavioral: professional audit and feedback (guideline adherence)
maximal interventionActive comparatormulti-faceted intervention consisting of professional and patient elements
Receives: Behavioral: patient education; Behavioral: professional audit and feedback (guideline adherence); Behavioral: professional education (communication/shared decision making); Other: information tools

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Extent of guideline adherence after approximately one year (measured by a specific set of guideline-derived indicators, formulated beforehand by the research group)

    Measured: half year after intervention

  2. Costs of both Implementation strategies

    Measured: half year after intervention

Secondary outcomes (1)

  1. Psychosocial patient characteristics after one year: fear, depression, satisfaction

    Measured: half year after intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jul 2005 (estimated)
  2. Study startOct 2005
  3. Primary completionFeb 2009 (estimated)
  4. Study completionMay 2009 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
5,200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00119925
Sponsor's protocol ID
SPRING 2005-01
Other IDs
ZonMw grant no. 945-14-116
Status last verified
Oct 2008
First submitted
5 Jul 2005
Last updated
29 Oct 2008
Results posted
No

Publications

  • Mourad SM, Hermens RP, Liefers J, Akkermans RP, Zielhuis GA, Adang E, Grol RP, Nelen WL, Kremer JA. A multi-faceted strategy to improve the use of national fertility guidelines; a cluster-randomized controlled trial. Hum Reprod. 2011 Apr;26(4):817-26. doi: 10.1093/humrep/deq299. Epub 2010 Dec 6.

    PubMed 21134950

Questions about this trial

What is this clinical trial studying?

A study testing patient education, professional audit and feedback (guideline adherence) and professional education (communication/shared decision making) in people with Male Infertility and Female Infertility, run by Radboud University Medical Center at 16 sites in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 29 Oct 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Selma M Mourad, MD (+31-24-3610590, s.mourad@kwazo.umcn.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Extent of guideline adherence after approximately one year (measured by a specific set of guideline-derived indicators, formulated beforehand by the research group) (time frame: half year after intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00119925, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2008.

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