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Patient-Centered Implementation Trial for Single Embryo Transfer

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ClinicalTrials.gov Identifier: NCT00315029
Recruitment Status : Completed
First Posted : April 17, 2006
Last Update Posted : October 27, 2008
Sponsor:
Collaborator:
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by:
Radboud University

Tracking Information
First Submitted Date  ICMJE April 14, 2006
First Posted Date  ICMJE April 17, 2006
Last Update Posted Date October 27, 2008
Study Start Date  ICMJE November 2006
Actual Primary Completion Date September 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 27, 2008)
Incidence choice for eSET [ Time Frame: after embryo transfer ]
Original Primary Outcome Measures  ICMJE
 (submitted: April 14, 2006)
  • Incidence choice for eSET
  • Cost-effectiveness combined implementation strategy
Change History Complete list of historical versions of study NCT00315029 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 27, 2008)
  • Patient knowledge [ Time Frame: during treatment ]
  • patient decisional conflict [ Time Frame: during treatment ]
  • Patient experiences [ Time Frame: duringg treatment ]
  • Pregnancy outcomes [ Time Frame: after treatment ]
  • Cost-effectiveness [ Time Frame: after follow up ]
Original Secondary Outcome Measures  ICMJE
 (submitted: April 14, 2006)
  • Patient knowledge
  • patient decisional conflict
  • Patient experiences
  • Pregnancy outcomes
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Patient-Centered Implementation Trial for Single Embryo Transfer
Official Title  ICMJE Patient-Centered Implementation of Elective Single Embryo Transfer (eSET) in in Vitro Fertilisation (IVF) and Intracytoplasmic Sperm Injection (ICSI)
Brief Summary

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.
Detailed Description see above
Study Type  ICMJE Interventional
Study Phase Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Male Infertility
  • Female Infertility
  • Pregnancy
Intervention  ICMJE
  • 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
Study Arms
  • Experimental: 1
    Receives combined patient centred intervention
    Interventions:
    • Behavioral: evidence based decision aid
    • Behavioral: Possible reimbursement 4th IVF/ICSI cycle when necessary
  • No Intervention: 2
    Standard treatment
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 24, 2008)
230
Original Enrollment  ICMJE
 (submitted: April 14, 2006)
210
Actual Study Completion Date October 2008
Actual Primary Completion Date September 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • Medical necessity for single embryo transfer
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 39 Years   (Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00315029
Other Study ID Numbers  ICMJE PITS2006
ZonMw nr 945-16-105
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Prof JAM Kremer, Radboud Universty Nijmegen Medical Centre
Study Sponsor  ICMJE Radboud University
Collaborators  ICMJE ZonMw: The Netherlands Organisation for Health Research and Development
Investigators  ICMJE
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
PRS Account Radboud University
Verification Date October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP