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
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||Phase|
|Male Infertility Female Infertility Pregnancy||Behavioral: evidence based decision aid Behavioral: Possible reimbursement 4th IVF/ICSI cycle when necessary||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||230 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Primary Completion Date :||September 2008|
|Actual Study Completion Date :||October 2008|
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
- Incidence choice for eSET [ Time Frame: after embryo transfer ]
- 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 ]
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
|Catharina ziekenhuis Eindhoven|
|Radboud University Nijmegen Medical Centre|
|Nijmegen, Netherlands, 6500HB|
|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|