Patient-Centered Implementation Trial for Single Embryo Transfer

Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00315029
• Other study ID #: PITS2006
• Secondary ID: ZonMw nr 945-16-
• Status: Completed
• Phase: N/A
• First received: April 14, 2006
• Last updated: October 24, 2008
• Start date: November 2006
• Est. completion date: October 2008

Study information

• Verified date: October 2008
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Description:

see above

Recruitment information / eligibility

• Status: Completed
• Enrollment: 230
• Est. completion date: October 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 39 Years

Eligibility

Inclusion Criteria:

• Female age < 39 years

• In first cycle minimum of two embryos available for transfer

Exclusion Criteria:

• Medical necessity for single embryo transfer

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Female Infertility
• Infertility
• Infertility, Female
• Infertility, Male
• Male Infertility
• Pregnancy

Intervention

Behavioral:
• evidence based decision aid
evidence based decision aid
• Possible reimbursement 4th IVF/ICSI cycle when necessary
Potential reimbursement 4th IVF/ICSI cycle when necessary

Locations

Country	Name	City	State
Netherlands	Catharina ziekenhuis Eindhoven	Eindhoven
Netherlands	Radboud University Nijmegen Medical Centre	Nijmegen

Sponsors (2)

Lead Sponsor	Collaborator
Radboud University	ZonMw: The Netherlands Organisation for Health Research and Development

Country where clinical trial is conducted

Netherlands, 

References & Publications (3)

Lukassen HG, Braat DD, Wetzels AM, Zielhuis GA, Adang EM, Scheenjes E, Kremer JA. Two cycles with single embryo transfer versus one cycle with double embryo transfer: a randomized controlled trial. Hum Reprod. 2005 Mar;20(3):702-8. Epub 2004 Dec 23. — View Citation

Lukassen HG, Schönbeck Y, Adang EM, Braat DD, Zielhuis GA, Kremer JA. Cost analysis of singleton versus twin pregnancies after in vitro fertilization. Fertil Steril. 2004 May;81(5):1240-6. — View Citation

Pandian Z, Templeton A, Serour G, Bhattacharya S. Number of embryos for transfer after IVF and ICSI: a Cochrane review. Hum Reprod. 2005 Oct;20(10):2681-7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence choice for eSET		after embryo transfer	No
Secondary	Patient knowledge		during treatment	No
Secondary	patient decisional conflict		during treatment	No
Secondary	Patient experiences		duringg treatment	No
Secondary	Pregnancy outcomes		after treatment	No
Secondary	Cost-effectiveness		after follow up	No