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Patient-Centered Implementation Trial for Single Embryo Transfer

This study has been completed.
Sponsor:
Collaborator:
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by:
Radboud University
ClinicalTrials.gov Identifier:
NCT00315029
First received: April 14, 2006
Last updated: October 24, 2008
Last verified: October 2008
History of Changes
  Purpose

Background: The number of multiple pregnancies is considered to be the most important adverse effect of in vitro fertilisation (IVF) and intracytoplasmic sperm injection (ICSI). IVF or ICSI with transferring only one embryo, elective single embryo transfer (eSET), will reduce this incidence remarkably. Unfortunately, former research has documented that cycles with SET maintain lower pregnancy rates compared to double embryo transfer (DET). Implementation of eSET will require a carefully chosen and thoroughly defined implementation strategy focussed on the couple undergoing the subfertility treatment. This trial will investigate the (cost)effectiveness of a combined patient centred implementation strategy.

Objective: The main aim is to compare the effectiveness and costs of implementation of elective single embryo transfer (eSET) in in vitro fertilisation (IVF) and intracytoplasmic sperm injection (ICSI), between usual care and a combined patient-centred strategy.

Study design: A randomised controlled trial

Study population: Couples with a female age less than 40 years ongoing an IVF/ICSI treatment in 2 of the 13 Dutch IVF centres and their 4 satellite/transport centres.

Intervention A combined patient centred implementation strategy for eSET in IVF/ICSI. The strategy consists of counselling through an evidence based decision aid and reimbursement of a 4th cycle if couples have chosen for eSET in the first 2 cycles.

Primary study parameters/outcome of the study: the eSET occurrence rate, pregnancy outcomes and cost-effectiveness of the combined strategy.

Secondary study parameters/outcome of the study:

  • patient knowledge
  • patient decisional conflict
  • patient satisfaction
  • IVF/ICSI treatment outcome.

Condition Intervention
Male Infertility
Female Infertility
Pregnancy
 Behavioral: evidence based decision aid
Behavioral: Possible reimbursement 4th IVF/ICSI cycle when necessary

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Patient-Centered Implementation of Elective Single Embryo Transfer (eSET) in in Vitro Fertilisation (IVF) and Intracytoplasmic Sperm Injection (ICSI)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Radboud University:

Primary Outcome Measures:
  • Incidence choice for eSET [ Time Frame: after embryo transfer ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patient knowledge [ Time Frame: during treatment ] [ Designated as safety issue: No ]
  • patient decisional conflict [ Time Frame: during treatment ] [ Designated as safety issue: No ]
  • Patient experiences [ Time Frame: duringg treatment ] [ Designated as safety issue: No ]
  • Pregnancy outcomes [ Time Frame: after treatment ] [ Designated as safety issue: No ]
  • Cost-effectiveness [ Time Frame: after follow up ] [ Designated as safety issue: No ]

Enrollment: 230
Study Start Date: November 2006
Study Completion Date: October 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Receives combined patient centred intervention
 Behavioral: evidence based decision aid
evidence based decision aid
Behavioral: Possible reimbursement 4th IVF/ICSI cycle when necessary
Potential reimbursement 4th IVF/ICSI cycle when necessary
No Intervention: 2
Standard treatment

Detailed Description:

see above

  Eligibility

Ages Eligible for Study:   18 Years to 39 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female age < 39 years
  • In first cycle minimum of two embryos available for transfer

Exclusion Criteria:

  • Medical necessity for single embryo transfer
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00315029

Locations
Netherlands
Catharina ziekenhuis Eindhoven
Eindhoven, Netherlands
Radboud University Nijmegen Medical Centre
Nijmegen, Netherlands, 6500HB
Sponsors and Collaborators
Radboud University
ZonMw: The Netherlands Organisation for Health Research and Development
Investigators
Principal Investigator: Rosella P Hermens, PhD Centre for Quality of Care Research (WOK), Radboud University Nijmegen Medical Centre
Principal Investigator: Jan AM Kremer, MD, PhD Department of Obstetrics & Gynaecology, Radboud University Nijmegen Medical Centre
Study Chair: Didi D Braat, Prof. MD PhD Department of Obstetrics and Gynaecology, Radboud University Nijmegen Medical Centre
Study Chair: Richard PT Grol, Prof. PhD Centre for Quality of Care Research (WOK), Radboud University Nijmegen Medical Centre
Principal Investigator: Willianne Nelen, MD, PhD Department of Obstetrics & Gynaecology, Radboud University Nijmegen Medical Centre
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Prof JAM Kremer, Radboud Universty Nijmegen Medical Centre
ClinicalTrials.gov Identifier: NCT00315029     History of Changes
Other Study ID Numbers: PITS2006, ZonMw nr 945-16-105
Study First Received: April 14, 2006
Last Updated: October 24, 2008
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Radboud University:
Implementation
Single embryo transfer
ICSI
IVF
prevention

Additional relevant MeSH terms:
Infertility
Infertility, Female
Infertility, Male
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on June 18, 2013