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Patient-Centered Implementation Trial for Single Embryo Transfer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00315029
Recruitment Status : Completed
First Posted : April 17, 2006
Last Update Posted : October 27, 2008
Sponsor:
Collaborator:
Information provided by:

Study Description
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.

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

Detailed Description:
see above

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 230 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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)
Study Start Date : November 2006
Primary Completion Date : September 2008
Study Completion Date : October 2008


Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Incidence choice for eSET [ Time Frame: after embryo transfer ]

Secondary Outcome Measures :
  1. Patient knowledge [ Time Frame: during treatment ]
  2. patient decisional conflict [ Time Frame: during treatment ]
  3. Patient experiences [ Time Frame: duringg treatment ]
  4. Pregnancy outcomes [ Time Frame: after treatment ]
  5. Cost-effectiveness [ Time Frame: after follow up ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 39 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
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
First Posted: April 17, 2006    Key Record Dates
Last Update Posted: October 27, 2008
Last Verified: October 2008

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

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