Decision MakingNCT03185715
Oocyte Recipient's Decision in the Number of Embryos to be Transferred
A study testing Oral and written counselling in people with Decision Making and Infertility, Female, run by Fundacion Dexeus.
Trial summary
Multiple pregnancies are considered an ART complication. The only effective way to reduce its incidence is to transfer a single embryo. Nonetheless, there is some reluctance among the patients to accept this strategy. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Decision Making, Infertility, Female, Counseling
- What is being tested?
- Oral and written counselling
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Oct 2014to May 2017
- 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients under their first oocyte or embryo donation cycle.
- Sufficient knowledge of Spanish to fill out questionnaires.
Who cannot join
- Patients with a medical indication for single embryo transfer (e.g. Turner syndrome, uterine surgeries, cardiovascular risk).
- Having had previous oocyte or embryo donation cycles.
- Insufficient knowledge of Spanish.
About this study
Official title: Single or Double Embryo Transfer? Decision-making Process in Patients Participating in an Oocyte Donation Program
Multiple pregnancies are considered an ART complication. The only effective way to reduce its incidence is to transfer a single embryo. Nonetheless, there is some reluctance among the patients to accept this strategy. In IVF/ICSI programs, it has been demonstrated that, after receiving the information about the similar cumulative live birth rate after single embryo transfer (SET) and double embryo transfer (DET) and the obstetric and perinatal risks of multiple pregnancy, a significant number of patients opt for SET. Up to date, no comparable studies have been published in oocyte recipients. The aim of this study is to evaluate if the information given to the patients influence their preference on the number of embryos to be transferred. It also seeks to identify factors which determine the initial preference and factors which can explain a hypothetic change in this preference.
- Conditions
- Decision Making, Infertility, Female, Counseling
- Being tested
- Oral and written counselling
- Keywords
- oocyte donation, recipient counselling, single embryo transfer (SET), double embryo transfer (DET), decision-making
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral and written counsellingBehavioural
Recipients were informed about success rates of SET and DET and also about the possible risks of DET. All the information was given orally and written.
| Study group | Role | What they receive |
|---|---|---|
| Counseling policy embryo transfer | Other | All recipients completed a validated self-report questionnaire on the preference on the number of embryos to be transferred and the relevance for the decision-making process attributed to certain factors. The questionnaire also included questions on sociodemographic characteristics, medical-reproductive background and cycle's results and risks perception. All recipients received oral and written counselling. After counselling, during the treatment, the recipients completed a second questionnaire in order to check if their decision had changed. Receives: Behavioral: Oral and written counselling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preference change on the number of embryos to be transferred
Preference was evaluated at the first consultation and after counselling using a self-report questionnaire.
Measured: Up to 3 months
Secondary outcomes (2)
Factors which determine the initial preference on the number of embryos to be transferred
Factor's weight is analysed using a self-report questionnaire. Each factor is scored 1-10 according its relevance.
Measured: At the first consultation
Factors which can explain a change in the preference on the number of embryos to be transferred
Each factor is scored 1-10 according its relevance. Score before counselling and score after counselling were compared.
Measured: Up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2017
- Study startOct 2014
- Primary completionMay 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Decision MakingStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacion Dexeus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elisabet Clua Obrado, Fundacion Dexeus
- Investigators
- Elisabet Clua, PhD, Principal investigator, Fundacion Dexeus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03185715
- Sponsor's protocol ID
- SMD-2014-121
- Status last verified
- Jun 2017
- First submitted
- 19 May 2017
- Last updated
- 14 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Land JA, Evers JL. Risks and complications in assisted reproduction techniques: Report of an ESHRE consensus meeting. Hum Reprod. 2003 Feb;18(2):455-7. doi: 10.1093/humrep/deg081.
PubMed 12571190van Peperstraten AM, Nelen WL, Hermens RP, Jansen L, Scheenjes E, Braat DD, Grol RP, Kremer JA. Why don't we perform elective single embryo transfer? A qualitative study among IVF patients and professionals. Hum Reprod. 2008 Sep;23(9):2036-42. doi: 10.1093/humrep/den156. Epub 2008 Jun 18.
PubMed 18565969Ryan GL, Sparks AE, Sipe CS, Syrop CH, Dokras A, Van Voorhis BJ. A mandatory single blastocyst transfer policy with educational campaign in a United States IVF program reduces multiple gestation rates without sacrificing pregnancy rates. Fertil Steril. 2007 Aug;88(2):354-60. doi: 10.1016/j.fertnstert.2007.03.001. Epub 2007 May 9.
PubMed 17490657Hope N, Rombauts L. Can an educational DVD improve the acceptability of elective single embryo transfer? A randomized controlled study. Fertil Steril. 2010 Jul;94(2):489-95. doi: 10.1016/j.fertnstert.2009.03.080. Epub 2009 May 13.
PubMed 19442970
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single or Double Embryo Transfer? Decision-making Process in Patients Participating in an Oocyte Donation Program
- ClinicalTrials.gov ID
- NCT03185715
- Acronym / sponsor ID
- SMD-2014-121
- Conditions
- Decision Making, Infertility, Female, Counseling
- Keywords
- oocyte donation, recipient counselling, single embryo transfer (SET), double embryo transfer (DET), decision-making
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Fundacion DexeusUniversity, hospital or other
- Study start
- Oct 2014 (actual)
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 14 Jun 2017 (actual)
- 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.
Multiple pregnancies are considered an ART complication. The only effective way to reduce its incidence is to transfer a single embryo. Nonetheless, there is some reluctance among the patients to accept this strategy. In IVF/ICSI programs, it has been demonstrated that, after receiving the information about the similar cumulative live birth rate after single embryo transfer (SET) and double embryo transfer (DET) and the obstetric and perinatal risks of multiple pregnancy, a significant number of patients opt for SET. Up to date, no comparable studies have been published in oocyte recipients. The aim of this study is to evaluate if the information given to the patients influence their preference on the number of embryos to be transferred. It also seeks to identify factors which determine the initial preference and factors which can explain a hypothetic change in this preference.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Counseling policy embryo transfer | Other | Behavioral: Oral and written counsellingAll recipients completed a validated self-report questionnaire on the preference on the number of embryos to be transferred and the relevance for the decision-making process attributed to certain factors. The questionnaire also included questions on sociodemographic characteristics, medical-reproductive background and cycle's results and risks perception. All recipients received oral and written counselling. After counselling, during the treatment, the recipients completed a second questionnaire in order to check if their decision had changed. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients under their first oocyte or embryo donation cycle.
- Sufficient knowledge of Spanish to fill out questionnaires.
Key exclusion criteria (3 listed)
- Patients with a medical indication for single embryo transfer (e.g. Turner syndrome, uterine surgeries, cardiovascular risk).
- Having had previous oocyte or embryo donation cycles.
- Insufficient knowledge of Spanish.
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 |
|---|---|---|
| Oral and written counsellingRecipients were informed about success rates of SET and DET and also about the possible risks of DET. All the information was given orally and written. | Behavioural | Counseling policy embryo transfer |
Primary outcome
Preference change on the number of embryos to be transferred
Time frame: Up to 3 months
Preference was evaluated at the first consultation and after counselling using a self-report questionnaire.
2 secondary outcomes
Factors which determine the initial preference on the number of embryos to be transferred
Time frame: At the first consultation
Factors which can explain a change in the preference on the number of embryos to be transferred
Time frame: Up to 3 months
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 14 Jun 2017.
- Background: PubMed 12571190Land JA, Evers JL. Risks and complications in assisted reproduction techniques: Report of an ESHRE consensus meeting. Hum Reprod. 2003 Feb;18(2):455-7. doi: 10.1093/humrep/deg081.
- Background: PubMed 18565969van Peperstraten AM, Nelen WL, Hermens RP, Jansen L, Scheenjes E, Braat DD, Grol RP, Kremer JA. Why don't we perform elective single embryo transfer? A qualitative study among IVF patients and professionals. Hum Reprod. 2008 Sep;23(9):2036-42. doi: 10.1093/humrep/den156. Epub 2008 Jun 18.
- Background: PubMed 17490657Ryan GL, Sparks AE, Sipe CS, Syrop CH, Dokras A, Van Voorhis BJ. A mandatory single blastocyst transfer policy with educational campaign in a United States IVF program reduces multiple gestation rates without sacrificing pregnancy rates. Fertil Steril. 2007 Aug;88(2):354-60. doi: 10.1016/j.fertnstert.2007.03.001. Epub 2007 May 9.
- Background: PubMed 19442970Hope N, Rombauts L. Can an educational DVD improve the acceptability of elective single embryo transfer? A randomized controlled study. Fertil Steril. 2010 Jul;94(2):489-95. doi: 10.1016/j.fertnstert.2009.03.080. Epub 2009 May 13.
- Individual participant dataSharing planned: No
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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.
Elisabet Clua, PhD principal investigator
Fundacion Dexeus
Questions about this trial
What is this clinical trial studying?
A study testing Oral and written counselling in people with Decision Making and Infertility, Female, run by Fundacion Dexeus.
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 3 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 14 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Preference change on the number of embryos to be transferred (time frame: Up to 3 months). 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 NCT03185715, which also lists 4 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 14 Jun 2017.