Male InfertilityNCT00315029
Patient-Centered Implementation Trial for Single Embryo Transfer
A study testing evidence based decision aid and Possible reimbursement 4th IVF/ICSI cycle when necessary in people with Male Infertility and Female Infertility, run by Radboud University Medical Center at 2 sites in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 to 39 years
- Conditions the study is for
- Male Infertility, Female Infertility, Pregnancy
- What is being tested?
- evidence based decision aid and Possible reimbursement 4th IVF/ICSI cycle when necessary
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- 2 sitesNetherlands
- Study dates
- Nov 2006to Oct 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 39 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Female age < 39 years
- In first cycle minimum of two embryos available for transfer
Who cannot join
- Medical necessity for single embryo transfer
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
Catharina ziekenhuis Eindhoven
Eindhoven
Radboud University Nijmegen Medical Centre
Nijmegen, 6500HB
About this study
Official title: Patient-Centered Implementation of Elective Single Embryo Transfer (eSET) in in Vitro Fertilisation (IVF) and Intracytoplasmic Sperm Injection (ICSI)
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.
Read more
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.
Read the detailed description
see above
- Conditions
- Male Infertility, Female Infertility, Pregnancy
- Being tested
- evidence based decision aid, Possible reimbursement 4th IVF/ICSI cycle when necessary
- Keywords
- Implementation, Single embryo transfer, ICSI, IVF, prevention
- Medical subject headings
- Infertility, Male, Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
evidence based decision aidBehavioural
evidence based decision aid
Possible reimbursement 4th IVF/ICSI cycle when necessaryBehavioural
Potential reimbursement 4th IVF/ICSI cycle when necessary
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Receives combined patient centred intervention Receives: Behavioral: evidence based decision aid; Behavioral: Possible reimbursement 4th IVF/ICSI cycle when necessary |
| 2 | No intervention | Standard treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence choice for eSET
Measured: after embryo transfer
Secondary outcomes (5)
Patient knowledge
Measured: during treatment
patient decisional conflict
Measured: during treatment
Patient experiences
Measured: duringg treatment
Pregnancy outcomes
Measured: after treatment
Cost-effectiveness
Measured: after follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2006 (estimated)
- Study startNov 2006
- Primary completionSep 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Male InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Investigators
- Rosella P Hermens, PhD, Principal investigator, Centre for Quality of Care Research (WOK), Radboud University Nijmegen Medical CentreJan AM Kremer, MD, PhD, Principal investigator, Department of Obstetrics & Gynaecology, Radboud University Nijmegen Medical CentreDidi D Braat, Prof. MD PhD, Study chair, Department of Obstetrics and Gynaecology, Radboud University Nijmegen Medical CentreRichard PT Grol, Prof. PhD, Study chair, Centre for Quality of Care Research (WOK), Radboud University Nijmegen Medical CentreWillianne Nelen, MD, PhD, Principal investigator, Department of Obstetrics & Gynaecology, Radboud University Nijmegen Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00315029
- Sponsor's protocol ID
- PITS2006
- Other IDs
- ZonMw nr 945-16-105
- Status last verified
- Oct 2008
- First submitted
- 14 Apr 2006
- Last updated
- 27 Oct 2008
- Results posted
- No
Publications
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. doi: 10.1093/humrep/dei153.
PubMed 16183994Lukassen 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. doi: 10.1093/humrep/deh672. Epub 2004 Dec 23.
PubMed 15618254Lukassen HG, Schonbeck 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. doi: 10.1016/j.fertnstert.2003.10.029.
PubMed 15136084Brabers AE, van Dijk L, Groenewegen PP, van Peperstraten AM, de Jong JD. Does a strategy to promote shared decision-making reduce medical practice variation in the choice of either single or double embryo transfer after in vitro fertilisation? A secondary analysis of a randomised controlled trial. BMJ Open. 2016 May 6;6(5):e010894. doi: 10.1136/bmjopen-2015-010894.
PubMed 27154481van Peperstraten A, Nelen W, Grol R, Zielhuis G, Adang E, Stalmeier P, Hermens R, Kremer J. The effect of a multifaceted empowerment strategy on decision making about the number of embryos transferred in in vitro fertilisation: randomised controlled trial. BMJ. 2010 Sep 30;341:c2501. doi: 10.1136/bmj.c2501.
PubMed 20884700
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-Centered Implementation of Elective Single Embryo Transfer (eSET) in in Vitro Fertilisation (IVF) and Intracytoplasmic Sperm Injection (ICSI)
- ClinicalTrials.gov ID
- NCT00315029
- Acronym / sponsor ID
- PITS2006
- Conditions
- Male Infertility, Female Infertility, Pregnancy
- Keywords
- Implementation, Single embryo transfer, ICSI, IVF, prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Study start
- Nov 2006
- Primary completion
- Sep 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 17 Apr 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
see above
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: evidence based decision aid, Behavioral: Possible reimbursement 4th IVF/ICSI cycle when necessaryReceives combined patient centred intervention |
| 2 | No intervention | –Standard treatment |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Female age < 39 years
- In first cycle minimum of two embryos available for transfer
Key exclusion criteria (1 listed)
- Medical necessity for single embryo transfer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| evidence based decision aidevidence based decision aid | Behavioural | 1 |
| Possible reimbursement 4th IVF/ICSI cycle when necessaryPotential reimbursement 4th IVF/ICSI cycle when necessary | Behavioural | 1 |
Primary outcome
Incidence choice for eSET
Time frame: after embryo transfer
5 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2008.
- Background: PubMed 16183994Pandian 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. doi: 10.1093/humrep/dei153.
- Background: PubMed 15618254Lukassen 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. doi: 10.1093/humrep/deh672. Epub 2004 Dec 23.
- Background: PubMed 15136084Lukassen HG, Schonbeck 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. doi: 10.1016/j.fertnstert.2003.10.029.
- Derived from this study: PubMed 27154481Brabers AE, van Dijk L, Groenewegen PP, van Peperstraten AM, de Jong JD. Does a strategy to promote shared decision-making reduce medical practice variation in the choice of either single or double embryo transfer after in vitro fertilisation? A secondary analysis of a randomised controlled trial. BMJ Open. 2016 May 6;6(5):e010894. doi: 10.1136/bmjopen-2015-010894.
- Derived from this study: PubMed 20884700van Peperstraten A, Nelen W, Grol R, Zielhuis G, Adang E, Stalmeier P, Hermens R, Kremer J. The effect of a multifaceted empowerment strategy on decision making about the number of embryos transferred in in vitro fertilisation: randomised controlled trial. BMJ. 2010 Sep 30;341:c2501. doi: 10.1136/bmj.c2501.
Related trials for Male Infertility
RecruitingObservational study
Inherited Reproductive Disorders
Genetic Disorder, Infertility
Active, not recruitingPhase 1/2
A Novel Aromatase Inhibitor, Leflutrozole, for Treatment of Non-Obstructive Azoospermia
Infertility Due to Azoospermia, Infertility, Male
Active, not recruiting
YO® Smartphone Home Sperm Test Versus Manual Semen Analysis in Egyptian Men
Semen Analysis, Male Infertility
RecruitingObservational study
Association of Ultrasound Features of the Myometrium Suggestive of Adenomyosis and Clinical Symptoms
Adenomyosis of Uterus
Not yet recruitingPhase 4
Comparative Efficacy of Antioxidants Alone Versus Combined Therapy With SERMs or FSH in Normogonadotropic Idiopathic OAT Patients: A Randomized Controlled Trial
Oligoasthenoteratozoospermia, Male Infertility
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rosella P Hermens, PhD principal investigator
Centre for Quality of Care Research (WOK), Radboud University Nijmegen Medical Centre
Jan AM Kremer, MD, PhD principal investigator
Department of Obstetrics & Gynaecology, Radboud University Nijmegen Medical Centre
Didi D Braat, Prof. MD PhD study chair
Department of Obstetrics and Gynaecology, Radboud University Nijmegen Medical Centre
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing evidence based decision aid and Possible reimbursement 4th IVF/ICSI cycle when necessary in people with Male Infertility and Female Infertility, run by Radboud University Medical Center at 2 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence choice for eSET (time frame: after embryo transfer). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00315029, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2008.