Patient-Centered Implementation Trial for Single Embryo Transfer

Study Overview
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Brief Summary
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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
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see above

Official Title
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Patient-Centered Implementation of Elective Single Embryo Transfer (eSET) in in Vitro Fertilisation (IVF) and Intracytoplasmic Sperm Injection (ICSI)

Conditions
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Pregnancy, Male Infertility, Female Infertility

Intervention / Treatment
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* Behavioral: evidence based decision aid
* Behavioral: Possible reimbursement 4th IVF/ICSI cycle when necessary


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female age < 39 years In first cycle minimum of two embryos available for transfer Exclusion Criteria: Medical necessity for single embryo transfer

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 39 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Receives combined patient centred intervention | Behavioral: evidence based decision aid<br>* evidence based decision aid<br>Behavioral: Possible reimbursement 4th IVF/ICSI cycle when necessary<br>* Potential reimbursement 4th IVF/ICSI cycle when necessary<br>|
| No Intervention: 2<br>Standard treatment | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence choice for eSET |  | after embryo transfer | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient knowledge |  | during treatment | 
| patient decisional conflict |  | during treatment | 
| Patient experiences |  | duringg treatment | 
| Pregnancy outcomes |  | after treatment | 
| Cost-effectiveness |  | after follow up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IVF, Implementation, Single embryo transfer, ICSI, prevention