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

Radboud University Medical Center

Status: Unknown

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

Treatments: Other: information tools; Behavioral: professional education (communication/shared decision making); Behavioral: patient education; Behavioral: professional audit and feedback (guideline adherence)

Study type: Interventional

Funder types: Other

Identifiers

NCT00119925

SPRING 2005-01

ZonMw grant no. 945-14-116

Details and patient eligibility

About

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.

Full 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.

Enrollment: 5,200 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

5,200 participants in 2 patient groups

minimal intervention

Active Comparator group

Description:

professional audit and feedback on current practice

Treatment:

Behavioral: professional audit and feedback (guideline adherence)

maximal intervention

Active Comparator group

Description:

multi-faceted intervention consisting of professional and patient elements

Treatment:

Other: information tools

Behavioral: patient education

Behavioral: professional audit and feedback (guideline adherence)

Behavioral: professional education (communication/shared decision making)