Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: 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.


Options:
A: Arm Label: 1; Type: EXPERIMENTAL; Interventions: Behavioral: evidence based decision aid, Behavioral: Possible reimbursement 4th IVF/ICSI cycle when necessary | Arm Label: 2; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: evidence based decision aid; Assigned to Arm(s): 1 | Intervention Type: BEHAVIORAL; Name: Possible reimbursement 4th IVF/ICSI cycle when necessary; Assigned to Arm(s): 1
B: Arm Label: Absolute risk reduction information; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Absolute risk reduction | Arm Label: Prolongation of life information; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Prolongation of life | Intervention Type: BEHAVIORAL; Name: Absolute risk reduction; Assigned to Arm(s): Absolute risk reduction information | Intervention Type: BEHAVIORAL; Name: Prolongation of life; Assigned to Arm(s): Prolongation of life information
C: Arm Label: 1; Type: EXPERIMENTAL; Interventions: Other: You Decide | Arm Label: 2; Type: ACTIVE_COMPARATOR; Interventions: Other: Reducing Your Risks in the Crash | Intervention Type: OTHER; Name: You Decide; Assigned to Arm(s): 1 | Intervention Type: OTHER; Name: Reducing Your Risks in the Crash; Assigned to Arm(s): 2
D: Arm Label: Decision aid; Type: ACTIVE_COMPARATOR; Interventions: Other: Decision Aid | Arm Label: Normal care; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: OTHER; Name: Decision Aid; Assigned to Arm(s): Decision aid

Answer: A