InfertilityGAB-RCTNCT04169295
Gynecologists' Feedback on ART-Birth Rates
A study testing Gynecologists' feedback on ART-Birth rates in people with Infertility, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
The investigators will examine the hypothesis that women who are given their personalized IVF-prognosis are less likely to overestimate their IVF-live birth rate, as compared to women who do not receive a personalized IVF-prognosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infertility
- What is being tested?
- Gynecologists' feedback on ART-Birth rates
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteBelgium
- Study dates
- 22 Nov 2019to 17 May 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Couples treated with a 2nd-6th fresh cycle of IVF (every couple can only participate ones in this study).
Who cannot join
- Couples treated with:
- Pre-implantation Genetic Testing (PGT)
- donated oocytes, sperm or embryos
- Spermatozoa obtained by testicular extraction
- HIV-positive diagnosis
- Embryo transfer on day 2
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Gynecologists' Feedback on Assisted Reproductive Technology (ART) Birth Rates: a Randomized Controlled Trial
The investigators will examine the hypothesis that women who are given their personalized IVF-prognosis are less likely to overestimate their IVF-live birth rate, as compared to women who do not receive a personalized IVF-prognosis.
Control group: At the time of their fresh embryo transfer couples will receive a document with a photo of their transferred embryo(s) and the number of cryopreserved embryos.
Intervention group: At the time of their fresh embryo transfer couples will receive a document with the following feedback: a photo of their transferred embryo, the number of cryopreserved embryos, the quality rating of the transferred embryo's, and couple's personalized IVF-prognosis (i.e. their chance on a live birth from the current IVF-cycle, including the transfer of fresh and if available cryopreserved embryos, calculated by entering eight background characteristics and five IVF-laboratory results into a prognostic model).
Read the detailed description
Primary outcome:
The proportion of women expecting their IVF-live birth rate to be double their calculated IVF-prognosis, directly after their fresh embryo transfer.
Secondary outcomes:
The proportion of men expecting their IVF-live birth rate to be double their calculated IVF-prognosis, directly after their fresh embryo transfer.
Women's and men's anxiety will be assessed with the reliable 'State-Anxiety Inventory, (STAI-state)' questionnaire, disseminated in coded paper-pencil format on the day of the fresh embryo transfer.
Patient's infertility-specific distress will be assessed with the reliable 'Infertility Distress Scale (IDS)' questionnaire, within two days of the conclusive pregnancy test after the transfer of the last (fresh or cryopreserved) embryo of the studied IVF-cycle.
- Conditions
- Infertility
- Being tested
- Gynecologists' feedback on ART-Birth rates, Control group
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gynecologists' feedback on ART-Birth ratesOther
At the time of their fresh embryo transfer couples will receive a document with the following feedback: a photo of their transferred embryo, the number of cryopreserved embryos, the quality rating of the transferred embryo's and couple's personalized IVF-prognosis (i.e. their chance on a live birth from the current IVF-cycle, including the transfer of fresh and if available cryopreserved embryos), calculated by entering eight background characteristics and five IVF-laboratory results into a prognostic model.
Control groupOther
At the time of their fresh embryo transfer couples will receive a document with the following feedback: a photo of their transferred embryo and the number of cryopreserved embryos
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | At the time of their fresh embryo transfer couples will receive a document with the following feedback: a photo of their transferred embryo, the number of cryopreserved embryos, the quality rating of the transferred embryo's, and couple's personalized IVF-prognosis Receives: Other: Gynecologists' feedback on ART-Birth rates |
| Control group | Sham comparator | At the time of their fresh embryo transfer couples will receive a document with a photo of their transferred embryo(s) and the number of cryopreserved embryos. Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of women over-estimating their IVF-live birth rate
The proportion of women expecting their IVF-live birth rate to be double their calculated IVF-prognosis, directly after their fresh embryo transfer.
Measured: Patient's expected IVF-live birth rate will be assessed immediately after the fresh embryo transfer with a single question coded paper-pencil questionnaire.
Secondary outcomes (3)
The proportion of men over-estimating their IVF-live birth rate
The proportion of men expecting their IVF-live birth rate to be double their calculated IVF-prognosis, directly after their fresh embryo transfer.
Measured: Patient's expected IVF-live birth rate will be assessed immediately after the fresh embryo transfer with a single question coded paper-pencil questionnaire.
Women's and men's anxiety
Women's and men's anxiety will be assessed with the reliable STAI-state questionnaire, disseminated in coded paper-pencil format on the day of the fresh embryo transfer.
Measured: Anxious feelings immediately after the fresh embryo transfer are assessed with the coded paper-pencil State Trait Anxiety Inventory, state module (STAI-state; 20-80, the higher, the more anxious)
Women's and men's infertility-specific distress
Women's and men's infertility-specific distress will be assessed with the reliable 'Infertility Distress Scale (IDS)' questionnaire, disseminated via text message and online
Measured: Infertility specific distress within 2 days of the conclusive pregnancy test after the the last embryotransfer (fresh or cryo) assessed with the Infertility Distress Scale (IDS; 8-40; the higher the more infertility specific distress)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2019
- Study start22 Nov 2019
- Primary completion26 Jan 2022
- Study completion17 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- GZA Ziekenhuizen Campus Sint-Augustinus
- Responsible party
- Sponsor
- Investigators
- Karen Peeraer, Prof., Principal investigator, Leuven University Fertilitycentre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04169295
- Sponsor's protocol ID
- s62972
- Acronym
- GAB-RCT
- Status last verified
- Jul 2024
- First submitted
- 12 Nov 2019
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gynecologists' Feedback on Assisted Reproductive Technology (ART) Birth Rates: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04169295
- Acronym / sponsor ID
- GAB-RCT / s62972
- Conditions
- Infertility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Collaborators
- GZA Ziekenhuizen Campus Sint-Augustinus
- Study start
- 22 Nov 2019 (actual)
- Primary completion
- 26 Jan 2022 (actual)
- Study completion
- 17 May 2023 (actual)
- First posted
- 19 Nov 2019 (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.
The investigators will examine the hypothesis that women who are given their personalized IVF-prognosis are less likely to overestimate their IVF-live birth rate, as compared to women who do not receive a personalized IVF-prognosis.
Control group: At the time of their fresh embryo transfer couples will receive a document with a photo of their transferred embryo(s) and the number of cryopreserved embryos.
Intervention group: At the time of their fresh embryo transfer couples will receive a document with the following feedback: a photo of their transferred embryo, the number of cryopreserved embryos, the quality rating of the transferred embryo's, and couple's personalized IVF-prognosis (i.e. their chance on a live birth from the current IVF-cycle, including the transfer of fresh and if available cryopreserved embryos, calculated by entering eight background characteristics and five IVF-laboratory results into a prognostic model).
Detailed description
Primary outcome:
The proportion of women expecting their IVF-live birth rate to be double their calculated IVF-prognosis, directly after their fresh embryo transfer.
Secondary outcomes:
The proportion of men expecting their IVF-live birth rate to be double their calculated IVF-prognosis, directly after their fresh embryo transfer.
Women's and men's anxiety will be assessed with the reliable 'State-Anxiety Inventory, (STAI-state)' questionnaire, disseminated in coded paper-pencil format on the day of the fresh embryo transfer.
Patient's infertility-specific distress will be assessed with the reliable 'Infertility Distress Scale (IDS)' questionnaire, within two days of the conclusive pregnancy test after the transfer of the last (fresh or cryopreserved) embryo of the studied IVF-cycle.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Gynecologists' feedback on ART-Birth ratesAt the time of their fresh embryo transfer couples will receive a document with the following feedback: a photo of their transferred embryo, the number of cryopreserved embryos, the quality rating of the transferred embryo's, and couple's personalized IVF-prognosis |
| Control group | Sham comparator | Other: Control groupAt the time of their fresh embryo transfer couples will receive a document with a photo of their transferred embryo(s) and the number of cryopreserved embryos. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Couples treated with a 2nd-6th fresh cycle of IVF (every couple can only participate ones in this study).
Key exclusion criteria (6 listed)
- Couples treated with:
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 |
|---|---|---|
| Gynecologists' feedback on ART-Birth ratesAt the time of their fresh embryo transfer couples will receive a document with the following feedback: a photo of their transferred embryo, the number of cryopreserved embryos, the quality rating of the transferred embryo's and couple's personalized IVF-prognosis (i.e. their chance on a live birth from the current IVF-cycle, including the transfer of fresh and if available cryopreserved embryos), calculated by entering eight background characteristics and five IVF-laboratory results into a prognostic model. | Other | Intervention group |
| Control groupAt the time of their fresh embryo transfer couples will receive a document with the following feedback: a photo of their transferred embryo and the number of cryopreserved embryos | Other | Control group |
Primary outcome
The proportion of women over-estimating their IVF-live birth rate
Time frame: Patient's expected IVF-live birth rate will be assessed immediately after the fresh embryo transfer with a single question coded paper-pencil questionnaire.
The proportion of women expecting their IVF-live birth rate to be double their calculated IVF-prognosis, directly after their fresh embryo transfer.
3 secondary outcomes
The proportion of men over-estimating their IVF-live birth rate
Time frame: Patient's expected IVF-live birth rate will be assessed immediately after the fresh embryo transfer with a single question coded paper-pencil questionnaire.
Women's and men's anxiety
Time frame: Anxious feelings immediately after the fresh embryo transfer are assessed with the coded paper-pencil State Trait Anxiety Inventory, state module (STAI-state; 20-80, the higher, the more anxious)
Women's and men's infertility-specific distress
Time frame: Infertility specific distress within 2 days of the conclusive pregnancy test after the the last embryotransfer (fresh or cryo) assessed with the Infertility Distress Scale (IDS; 8-40; the higher the more infertility specific distress)
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 3 Jul 2024.
- 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.
Karen Peeraer, Prof. principal investigator
Leuven University Fertilitycentre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gynecologists' feedback on ART-Birth rates in people with Infertility, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 1 inclusion and 6 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 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. 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. Some participants in this study may receive a placebo. 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?
The proportion of women over-estimating their IVF-live birth rate (time frame: Patient's expected IVF-live birth rate will be assessed immediately after the fresh embryo transfer with a single question coded paper-pencil questionnaire.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Jul 2024.