Gynecologists' Feedback on Assisted Reproductive Technology (ART) Birth Rates: a Randomized Controlled Trial
Phase: NA
Conditions: Infertility
Sponsor: Universitaire Ziekenhuizen KU Leuven

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Protocol full title Randomized Controlled Trial: 
Gynecologists’ feedback on ART-Pregnancy rates: a randomized controlled trial (s62972) 
Acronym: 
GAP-RCT 
Version and date of final protocol: 
Version 3, September 30th, 2019 
Sponsor: 
Name:        UZ Leuven 
address:        Herestraat 49, 3000 Leuven, Belgium 
Principal investigator UZ Leuven: 
Name:            Prof. dr. Karen Peeraer  
Address:        Herestraat 49, 3000 Leuven, Belgium 
Telephone:    016 34 36 50 
E-mail:           karen.peeraer@uzleuven.be 
Lead investigator GZA: 
Name:            Prof. dr. Peter De Loecker  
Address:        Oosterveldlaan 24, 2610 Wilrijk, Belgium 
Telephone:    03 443 36 05 
E-mail:           peterdeloecker@gmail.com 
Sub-investigators KU Leuven and UZ Leuven: 
Name:            Dr Eline Dancet  
Address:        Herestraat 49, 3000 Leuven, Belgium 
Telephone:    +32 479 63 57 11  
E-mail:           Eline.Dancet@kuleuven.be 
 
Name:            Johanna Devroe 
Address:        Herestraat 49, 3000 Leuven, Belgium 
Telephone:    016 34 08 31 
E-mail:           johanna.devroe@uzleuven.be 
Sub-investigators GZA:  
Name:            dr. Brecht Geysenbergh  
Address:        Oosterveldlaan 24, 2610 Wilrijk, Belgium 
Telephone:    03 443 36 05 
E-mail:           brecht_g@hotmail.com 
 
Name:            Louise Dias  
Address:        Oosterveldlaan 24, 2610 Wilrijk, Belgium 
Telephone:   03 443 36 05 
E-mail:           louise.dias@gza.be 
Signature and date: 
 
 
30-09-2019 
 
 
 
 
 
 
 
    
 
 
Professor. Dr. Karen Peeraer  
 
 
 
 
 
 
  

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0. Study synopsis 
Study title 
Gynecologists’ feedback on ART-Pregnancy rates: a Randomized Controlled Trial 
Short title 
GAP-RCT 
Sponsor name 
KU Leuven 
Principal Investigator 
Professor Dr. Karen Peeraer (UZ Leuven) 
Medical condition/ disease 
under investigation 
Infertility treated with IVF 
Study purpose 
We 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  
(i.e.      ,         ,  ,                   ,                     ), 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). 
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, disseminated via text message and online within 
two days of the conclusive pregnancy test after the transfer of the last (fresh or 
cryopreserved) embryo of the studied IVF-cycle.  
Background variables 
The following variables that potentially affect patient’s expected live birth rate will 
be extracted from patient’s medical file: whether they already had an ART-child (i.e. 
yes/no) and how many unsuccessful embryo transfers they had in the past (i.e. 
number). In addition, both partner’s general optimism, will be assessed with the 
reliable questionnaire ‘LOT-R’ which will be disseminated in coded paper-pencil 
format on the day of oocyte aspiration.  
Feasibility outcome 
On the day of their fresh embryo transfer, men and women will be asked to fill out 
two questions on uptake and evaluation of the standardized personalized 
feedback. 

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Follow-up outcomes 
Long-term clinical and compliance outcomes will be followed-up in couple’s 
medical chart 12-18 months after the oocyte aspiration. More specifically, the 12-
months cumulative clinical live birth rates for the observed oocyte aspiration will 
be extracted from the medical chart. In addition, the following compliance 
outcomes will be extracted: (i) censored by their medical doctor to discontinue IVF 
(yes-no) , (ii) number of untreated cycles within 12-months after oocyte aspiration 
and prior to the start of a new fresh cycle while not pregnant (i.e. IVF-delay), (iii) 
whether or not a subsequent IVF-cycle was started within twelve months after the 
last failed pregnancy test while not pregnant and no medical censoring to 
discontinue (i.e. IVF-discontinuation). 
Study design 
RCT (computerized randomization; 1/1 allocation sequence; no blinding) 
Endpoints 
The expected IVF live birth rate, anxiety and infertility specific distress of women 
and men. 
Sample size 
Hypothesizing that the intervention can lower the proportion of women expecting 
their live birth rate to be double their calculated IVF-prognosis from 50% to 25% 
dictates a sample size of 64 women per group (two-sided test; power 80%; α=0.05; 
G*Power). To account for a 15% chance of study drop-out due to not filling-out the 
questionnaires or loss of follow-up, 74 80 women will be recruited per group. 
Summary of eligibility 
criteria 
Inclusion criteria: Couples treated with a 2nd-6th fresh cycle of IVF (i.e. IVF with 
or without ICSI; every couple can only participate ones in this study).   
Exclusion criteria, Couples treated with:  
 
Pre-implantation Genetic Diagnosis (PGD)  
 
donated oocytes, sperm or embryos  
 
Spermatozoa obtained by testicular extraction (ICSI-CRYO-TESE) 
 
HIV-positive diagnosis 
 
Embryo transfer on day 2  
Maximum duration of 
study participation for 
a subject 
Study participation will be during one IVF-cycle. Men and women of eligible 
couples will be asked to each fill out a questionnaire on the day of oocyte 
aspiration, on the day of fresh embryo transfer and within two days of the 
pregnancy test after the transfer of the last embryo. Filling out each questionnaire 
takes 5 minutes. 
Version and date of final 
protocol 
Version 3, September 30, 2019 
Version and date of protocol 
amendments 
Not applicable 

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1. 
Background and rationale 
 
The general population is known to overestimate in vitro fertilisation (IVF) success rates1,2. Qualitative interviews 
showed that well informed women cryopreserving their oocytes were unrealistically optimistic about their own chances 
of having a child as they thought they and/or their gynaecologist were better than average3. To the best of our 
knowledge, the live birth rates expected by infertile couples during their IVF-cycle (i.e. in real life treatment situations) 
has yet to be studied. In addition, whether these expected live birth rates are affected by factors like gender, previous 
treatment experiences and level of optimism is unknown.  
IVF-success rates expected by patients are especially relevant since patients shared in interviews that the combination 
of unrealistically high expected live birth rates and repeated unsuccessful IVF-cycles, caused distress, which ultimately 
led to discontinuation from IVF4. The association between patient’s expected IVF-success rates and their level of distress 
experienced at the time of a negative pregnancy test and decision to discontinue IVF has yet to be quantified 
prospectively.  
Fertility patients have indicated that they want personalized information, for example on which success rate to expect5-
7. Recently, prognostic models that calculate personalized and cycle-specific success rates, have been developed and 
validated8,9.  So far, no study has examined whether gynaecologist’s feedback to couples about their personalized IVF-
prognosis influences patient’s expected IVF-success rate.  
Based on retrospective analysis of data from couples treated with a 2nd - 6th IVF-cycle by our laboratory, our group 
developed a model to give couples a personalized IVF-prognosis on the day of their embryo transfer based on eight 
background characteristics and five IVF-laboratory results from their current IVF-cycle. Our prognostic model performs 
exceptionally well as compared to previously published models. More specifically, our model has a c-statistic of 0.74 
and the c-statistic of previously published IVF-models ranges between 0.50 and 0.739-15  
 
2. 
Study objectives and design 
2.1 Study objective 
We 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.  
2.2 Study design 
At the time of oocyte aspiration, patients will be randomised in two groups:  
 
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 (Appendix 5): a photo of their transferred embryo,  the number of cryopreserved embryos, 
the quality rating  of the transferred embryo’s  (i.e.      ,          ,               ,                    , appendix 6), 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 model8,9 (Appendix 7). 
Firstly, we wish to analyse whether personalized information on IVF-prognosis on the day of their fresh embryo transfer 
results in more realistic expected IVF-live birth rates.  
Secondly, we wish to evaluate whether sharing these IVF-prognosis with patients at the time of embryo transfer is 
associated with the anxiety experienced by patients. 
Thirdly, we wish to explore whether these IVF-live birth rates expected by patients are associated with the infertility 
specific distress experienced by patients at the time of a negative pregnancy test. 
Fourthly, we wish to follow-up whether these IVF-live birth rates expected by patients are associated with clinical and 
compliance outcomes. 

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2.3 Study parameters/endpoints 
The primary endpoint is the proportion of women expecting directly after their fresh embryo transfer that their IVF-
live delivery birth rate to be double their calculated IVF-prognosis (i.e. women’s expected live birth rate ≥ 2*prognose) 
In addition the proportion of men expecting their IVF-live birth rate to be double their calculated IVF-prognosis will 
be studied. Patient’s expected IVF-live birth rates will be assessed  immediately after the fresh embryo transfer with a 
single question coded paper-pencil questionnaire. 
Women’s and men’s anxiety will be assessed with the reliable ‘State-Anxiety Inventory, (STAI-state)’ questionnaire16 17 
disseminated in coded paper-pencil format on the day of the fresh embryo transfer (Appendix 3). The STAI-state 
questionnaire includes 20 questions rated on a-four-point-Likert scale and results in a score between 20 to 80 (the 
higher, the more anxiety). 
Patient’s infertility-specific distress will be assessed with the reliable ‘Infertility Distress Scale (IDS)’ questionnaire 18, 
which has been translated reciprocally to Dutch (Appendix 4). The IDS questionnaire will be disseminated via text 
message and online within two days of the conclusive pregnancy test after the transfers of the last (fresh or 
cryopreserved) embryo of the studied IVF-cycle. The IDS questionnaire includes eight questions to be rated on a-five-
point-Likert scale and results in a score between 8 and 40 (the higher, the more infertility specific distress, Appendix 4). 
 
2.4 Follow-up parameters/endpoints 
Long-term clinical and compliance outcomes will be followed-up in couple’s medical chart twelve-eighteen months 
after the oocyte aspiration. More specifically, the 12-months cumulative clinical live birth rates for the observed oocyte 
aspiration will be extracted from the medical chart. In addition, the following compliance outcomes will be extracted: 
(i) censored by their medical doctor to discontinue IVF, (ii) number of untreated cycles within 12-months after oocyte 
aspiration and prior to the start of a new fresh cycle while not pregnant (i.e. IVF-delay), (iii) whether or not a subsequent 
IVF-cycle was started within twelve months after the last failed pregnancy test while not pregnant and no medical 
censoring to discontinue (i.e. IVF-discontinuation;19,20) 
 
2.5 Study design 
RCT (computerized randomization; 1/1 allocation sequence; no blinding) 
 
3. 
Methodology 
3.1 Study population and sample size 
3.1.1 
Study population  
Inclusion criteria: 
All couples treated at the Sint Augustinus Fertility clinic (Wilrijk) with a 2nd-6th fresh cycle of IVF are eligible. IVF includes 
IVF with or without ICSI and every couple can only participate ones in this study. Couples treated with their first IVF-
cycle are not eligible, since they are not the priority target population for this study. According to qualitative research 
discontinuation from IVF can amongst others be explained by the combination of high expectations regarding IVF-live 
birth rates and having experienced several cycles of unsuccessful IVF.   
Exclusion criteria: 
 
Couples going through IVF because they have an indication for Pre-implantation Genetic Diagnosis (PGD) are 
excluded as this study explores possible associations between IVF live birth rates expected by patients and infertility 
specific distress. The latter is less relevant to PGD-couples who turn to IVF for a genetic indication and not because 
of fertility problems. 
 
Couples treated with donated oocytes, sperm or embryos 
 
Couples treated with spermatozoa obtained by testicular extraction (ICSI-CRYO-TESE) 
 
HIV-positive patients  

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3.1.2 
Sample size calculation 
Hypothesizing that the intervention can lower the proportion of women expecting their live birth rate to be double their 
calculated IVF-prognosis from 50% to 25% dictates a sample size of 64 women per group (two-sided test; power 80%; 
α=0.05; G*Power). To account for a 25% chance of study drop-out due to no embryos for transfer, not filling-out the 
questionnaires or loss of follow-up, 80 women will be recruited per group. 
 
3.2 Study procedures including recruitment and data-collection 
The main outcomes of this study are gathered on the days of OPU and Embryo transfer  as presented in figure 1. 
 
Figure 1: Study procedure and data collection for participating couples of the GAP-RCT 
 
On the day of their oocyte aspiration, couples will be informed on the study and asked for their informed consent. 
Consenting men and women of eligible couples will be asked to each fill out a questionnaire on expected live birth rate 
(Appendix 1) and the LOT-R questionnaire (Appendix 2) on general optimism.  
On the day of their fresh embryo transfer, couples are randomized. Couples in the control group receive a document 
with a photo of their embryo(s) and the number of cryopreserved embryos. Couples in the intervention group receive a 
document with a photo of their transferred embryo(s), its quality rating, the number of cryopreserved embryos and 
couple’s personalized IVF-prognosis (Appendix 5). Men and women of both groups will be asked to fill out the 
questionnaire on expected live birthrate (Appendix 1) and the STAI-state questionnaire on anxiety (Appendix 3).  
Within two days of the conclusive pregnancy test after the transfers of the last (fresh or cryopreserved) embryo of the 
studied IVF-cycle, the IDS questionnaire on Patient’s infertility-specific distress 18 will be disseminated via text message 
and online (appendix 4). 
Eighteen months after the embryo transfer of the last (fresh or cryopreserved) embryo of the studied IVF-cycle, the 
researchers will follow-up the long-term clinical and compliance outcomes in patient’s medical chart (i.e. censored by 
their medical doctor to discontinue IVF, IVF-delay and IVF-discontinuation). 
 
3.3 Withdrawal of individual subjects 
Subjects can stop their participation in study at any time without having to give a reason. If this happens, only the data 
collected until that point will be used.  
 
 
 

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4. 
Data-analysis 
4.1 Overall statistical considerations 
The collected data will be imported into the ‘Statistical Package for the Social Sciences (SPSS)’.  
The previously proven reliability of the scales of the LOT-R, the STAI-state and the IDS will be re-evaluated by calculating 
Cronbach’s alpha statistics and Item Total Correlations.  
The collected data will be described with absolute values or percentages for categorical variables and with measures of 
dispersion (e.g. mean and standard deviation) for continuous variables, which is in line with the standard method of 
analysis of the used standardized LOT-R, STAI-state and IDS questionnaires.  
The gathered data will be described separately for men and women.  We will, however, explore whether partners differ 
in expected live birth rates, general optimism and infertility specific distress with paired t-tests. In addition, whether 
partner’s influence each other regarding these three outcomes and whether this is affected by gender will be explored 
with linear mixed models. 
 
A p-value ≤0.05 will be considered statistically significant.  
 
4.2 IVF-live birth rates expected by patients  
The IVF-live birth rates expected by patients will be analysed for both groups and for men and women separately. We 
will conduct an intention to treat analysis, primarily focussing on whether the intervention and the control group differ 
in the likeliness that women expect a live birth rate, which is at least twice as big as their prognosis. The difference in 
this binominal outcome will be analysed with a Chi2-test. A p-value ≤0.05 will be considered statistically significant. To 
also inform readers about the extent of the potential difference, proportions of the primary outcome will be reported 
per group and the 95% confidence interval of the difference in proportions of the primary outcome between both groups 
(i.e. if significant, it will not include 0) will also be reported21,22. 
4.3 Quantification of the under/over estimation of the live birth rates expected by patients 
In addition to the primary outcome (i.e. evaluating the proportion of women expecting their IVF-live birth rate to be 
double their calculated IVF-prognosis directly after their fresh embryo transfer) we want to quantify this under/over 
estimation. This will be calculated using the following formula: (expected LBR-prognosis)/prognosis. A positive sign 
shows overestimation, a negative sign shows underestimation and the absolute value quantifies the extend of the 
over/underestimation. For both groups, the mean and SD will be calculated. In addition, the mean difference in 
misjudgement between both groups and it’s 95% confidence interval (i.e. to give an impression of the preciseness of 
this estimation) will be reported21. 
 
4.4 Anxiety experienced by patients  
Whether the intervention and control group, differ in anxiety on the day of their embryo transfer will be analysed by 
comparing both groups STAI-state with an independent sample t-test. A p-value ≤0.05 will be considered statistically 
significant and the mean difference in anxiety between both groups and it’s 95% confidence interval will be reported21. 
 
4.5 Association between patient’s general optimism and their expected live birth rates 
Furthermore, we will assess in the entire sample with linear mixed models including ‘couple number’ as a random factor 
to take account of clustering within couples,  if patient’s general level of optimism is associated to their expected live 
birth rate.  
4.6 Association between IVF-live birth rates expected by patients and infertility specific distress 
Whether the intervention and control group, differ in infertility specific distress on the day of their embryo transfer will 
be analysed by comparing both group’s IDS-score with an independent sample t-test. A p-value ≤0.05 will be considered 
statistically significant and the mean difference in infertility specific distress between both groups and it’s 95% 

8 
 
confidence interval will be reported21.   In addition, a linear (mixed or non-mixed) model will explore in the entire sample 
whether IVF-live birth rates expected by patients are associated with their infertility specific distress. We will examine 
whether gender significantly (p≤0.05) affects the association between the IVF-live birth rate expected by patients and 
their infertility specific distress. If it does, we will rely on linear (non-mixed) models per gender. If it does not, we will 
rely on linear mixed models while including ‘couple number’ as a random factor to take account of clustering within 
couples, as partners cannot be considered independent cases 23,24.  
4.7 Follow-up outcomes  
Whether the intervention and control group, differ in one long-term clinical (i.e. the 12-months cumulative clinical live 
birth rates for the observed oocyte aspiration) and three compliance outcomes, followed-up in patient’s medical chart, 
will be analysed. The association between expected live birth rates and these long-term outcomes will also be explored 
on data from the entire sample. 
5. 
Direct access to source data and documents 
For this RCT no study-related monitoring or audits are planned. The EC review, and regulatory inspections (where 
appropriate) shall provide direct access to source data and other documents (i.e. patients’ case sheets, etc.). 
 
6. 
Safety reporting 
6.1 Definitions 
6.1.1 
Adverse Events (AEs) 
An AE is any untoward medical occurrence in a patient or clinical study subject administered a pharmaceutical product 
and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavourable 
and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the 
use of a medicinal product, whether or not considered related to the medicinal product. 
6.1.2 
Adverse Reactions (ARs) 
An AR is a response to a medicinal product or experiment which is noxious and unintended. Response in this context 
means that a causal relationship between a medicinal product or study-related intervention and an AE is at least a 
reasonable possibility. ARs may arise from use of the product within or outside the terms of the marketing authorization 
or from occupational exposure. Conditions of use outside the marketing authorization include Special Situations. 
For reporting purposes to Funder of this study, only AR related to a medicinal product of Funder must be documented 
by the site staff. An AR related to the intervention on the study must also be documented by the site staff, but not 
reported to the Funder. 
6.1.3 
Serious Adverse Reactions (SARs) 
A SAR is any AR as defined above, which also fulfils at least one of the seriousness criteria below: 
 
results in death; 
 
is life threatening (at the time of the event); 
 
requires hospitalization or prolongation of existing inpatients’ hospitalization; 
 
results in persistent or significant disability or incapacity; 
 
is a congenital anomaly or birth defect; 
 
that required medical or surgical intervention to preclude of any other important medical event that did not 
result in any of the outcomes listed above due to medical or surgical intervention but could have been based 
upon appropriate medical judgement. An elective hospital admission will not be considered as a serious 
adverse event. 
The investigator will report all SARs to the sponsor without undue delay after obtaining knowledge of the events. 
6.1.4 
Special Situations with regards to a medicinal product of Funder 
 
Use of such medicinal product during pregnancy or breastfeeding: reports where embryo, fetus or child may 
have been exposed to medicinal products (either through maternal exposure or transmission of a medicinal 
product via semen following paternal exposure); 
 
Reports of overdose, abuse, off-label use, misuse, medication error or occupational exposure; 

9 
 
 
Lack of therapeutic efficacy; 
 
Prescription error/dispensing error, e.g., due to confusion of invented names of the medicinal products; 
 
Drug interaction; 
 
Suspected transmission of an infectious agent via a medicinal product; or 
 
Product complaints (incl. falsified products or counterfeit products). 
The investigator will report all above listed situations to the sponsor without undue delay after obtaining knowledge of 
the events. 
6.1.5 
Emerging Safety Issues 
Safety issues are events/observations which may occur in relation to a medicinal product of Funder and which may have 
major impacts on the risk-benefit balance of the product and/or patients or public health. 
6.2 Recording of adverse events 
Safety events will be recorded from informed consent signature until the day of their last embryo transfer. This study 
does not affect couple’s treatment and we do not expect physical risks from giving patients their personalized prognosis. 
The personalized prognosis might, however, increase anxiety on the day of embryo transfer and this will be monitored 
with a validated questionnaire during the study. In addition, participant’s reports of distress, potentially made to medical 
doctors during embryo transfer or reported on the questionnaire administered directly after the transfer will be 
registered.  
The participant will be asked to report any adverse event related to the study-specific intervention to the study team. 
These reported events will be documented by the Investigator in the source documents. The following minimum 
information should be recorded for each AR: 
 
AE description of the adverse events 
 
Start and stop date of the AR 
 
Severity 
 
Seriousness 
 
Causality assessment to the study interventions 
 
Outcome 
 
6.3 Reporting to the Ethics Committee 
The sponsor will assess whether any relevant safety information that becomes available during the study should be 
reported ad hoc to the EC. 
The sponsor has the obligation to, once a year throughout the clinical trial (or on request), submit a progress report to 
the EC containing an overview of all SARs occurred during the reporting period and taking into account all new available 
safety information received during the reporting period. 
 
7. 
Ethics and regulatory approvals 
7.1 Regulation statement 
The study will be conducted in compliance with the principles of the Declaration of Helsinki (Fortaleza, Brazil, October 
2013) and in accordance with the Medical Research Involving Human Subjects Act (WMO) and other guidelines, 
regulations and Acts. 
The study protocol and all other study-related information shall be submitted to the Ethics Committees of the 
Participating Sites and the national competent authorities where applicable, in order to obtain prior approval before 
the study is initiated, unless such submission to the Ethics Committee is not required by applicable national legislation 
or in the event of a waiver for submission has been granted. Any subsequent protocol amendments will be submitted 
to the appropriate Ethics Committees and national Regulatory Authorities for approval. 
Unless not required by applicable national legislation, the study will be conducted only on the basis of prior informed 
consent by the study subjects, or their legal representatives, to participate in the study. The Participating Site shall 

10 
 
obtain a signed informed consent form (ICF) for all patients prior to their enrolment and participation in the study in 
compliance with all applicable laws, regulations and the approval of the (local) Ethics Committee, if required. The 
Participating Site shall retain such ICFs in accordance with the requirements of all applicable regulatory agencies and 
laws. 
The Investigator and the Participating Site shall treat all information and data relating to the study disclosed to 
Participating Site and/or Investigator in this study as confidential and with respect for the study participant’s privacy 
and shall not disclose such information to any third parties or use such information for any purpose other than the 
performance of the study. The collection, processing and disclosure of personal data, such as patient health and medical 
information is subject to compliance with applicable personal data protection and the processing of personal data (EU 
Directive 95/46/EC and its transposing national legislation). 
The data shall be coded, which means that there continues to be a link between the data and the individual who 
provided it. The research team is obligated to protect the data from disclosure outside the research team according to 
the terms of the research protocol and the informed consent document. The subject’s name or other identifiers should 
be stored separately from their research data and replaced with a unique code to create a new identity for the subject. 
Note that coded data are not anonymous. 
7.2 Recruitment and consent 
Couples will be asked for informed consent on the day of their oocyte aspiration. Patients who agree to participate will 
be asked to sign a written informed consent of which they will receive a copy.  
7.3 Compensation for injury 
The sponsor has obtained dispensation from the statutory obligation to provide insurance. Due to the nature of the 
study, there are no additional risks. 
8. 
Publication policy 
The parties agree that publications or presentations of any of the results from the study shall be in accordance with 
accepted scientific practice, academic standards and customs. It is anticipated that the results of the overall study shall 
be published in an international peer reviewed journal. Publications will be coordinated by Dr. Dancet. Authorship to 
publications will be determined in accordance with the requirements published by the International Committee of 
Medical Journal Editors and in accordance with the requirements of the respective medical journal. 
9. 
Insurance/indemnity 
Sponsor shall be liable, even without fault, for any damages incurred by a study patient and linked directly or indirectly 
to the participation to the study. Sponsor shall enter into an insurance agreement in order to cover the liability for any 
damages incurred by the Belgian study participants. 
10.  Funding  
Not applicable.  

11 
 
11. References  
 
1 
Lampic, C., Svanberg, A. S., Karlstrom, P. & Tyden, T. Fertility awareness, intentions concerning childbearing, and 
attitudes towards parenthood among female and male academics. Hum Reprod 21, 558-564, 
doi:10.1093/humrep/dei367 (2006). 
2 
Skoog Svanberg, A., Lampic, C., Karlstrom, P. O. & Tyden, T. Attitudes toward parenthood and awareness of 
fertility among postgraduate students in Sweden. Gender medicine 3, 187-195 (2006). 
3 
de Groot, M. et al. Perceptions of oocyte banking from women intending to circumvent age-related fertility 
decline. Acta Obstet Gynecol Scand 95, 1396-1401, doi:10.1111/aogs.13019 (2016). 
4 
Peddie, V. L., van Teijlingen, E. & Bhattacharya, S. A qualitative study of women's decision-making at the end of 
IVF treatment. Hum Reprod 20, 1944-1951, doi:10.1093/humrep/deh857 (2005). 
5 
Dancet, E. A. et al. The ENDOCARE questionnaire guides European endometriosis clinics to improve the patient-
centeredness of their care. Hum Reprod 27, 3168-3178, doi:10.1093/humrep/des299 (2012). 
6 
Dancet, E. A. et al. Patient-centred infertility care: a qualitative study to listen to the patient's voice. Hum Reprod 
26, 827-833, doi:10.1093/humrep/der022 (2011). 
7 
Tuil, W. S., ten Hoopen, A. J., Braat, D. D. M., de Vries Robbé, P. F. & Kremer, J. A. M. Patient-centred care: using 
online personal medical records in IVF practice. Human Reproduction 21, 2955-2959, doi:10.1093/humrep/del214 
(2006). 
8 
van Loendersloot, L. L., van Wely, M., Repping, S., Bossuyt, P. M. & van der Veen, F. Individualized decision-
making in IVF: calculating the chances of pregnancy. Hum Reprod 28, 2972-2980, doi:10.1093/humrep/det315 
(2013). 
9 
Sarais, V. et al. Predicting the success of IVF: external validation of the van Loendersloot's model. Hum Reprod 31, 
1245-1252, doi:10.1093/humrep/dew069 (2016). 
10 
Coppus, S. F., van der Veen, F., Opmeer, B. C., Mol, B. W. & Bossuyt, P. M. Evaluating prediction models in 
reproductive medicine. Hum Reprod 24, 1774-1778, doi:10.1093/humrep/dep109 (2009). 
11 
Leijdekkers, J. A. et al. Predicting the cumulative chance of live birth over multiple complete cycles of in vitro 
fertilization: an external validation study. Hum Reprod 33, 1684-1695, doi:10.1093/humrep/dey263 (2018). 
12 
McLernon, D. J., Steyerberg, E. W., Te Velde, E. R., Lee, A. J. & Bhattacharya, S. Predicting the chances of a live 
birth after one or more complete cycles of in vitro fertilisation: population based study of linked cycle data from 
113 873 women. BMJ (Clinical research ed.) 355, i5735, doi:10.1136/bmj.i5735 (2016). 
13 
Nelson, S. M. & Lawlor, D. A. Predicting live birth, preterm delivery, and low birth weight in infants born from in 
vitro fertilisation: a prospective study of 144,018 treatment cycles. PLoS Med 8, e1000386, 
doi:10.1371/journal.pmed.1000386 (2011). 
14 
Smith, A. D., Tilling, K., Lawlor, D. A. & Nelson, S. M. External validation and calibration of IVFpredict: a national 
prospective cohort study of 130,960 in vitro fertilisation cycles. PLoS One 10, e0121357, 
doi:10.1371/journal.pone.0121357 (2015). 
15 
te Velde, E. R. et al. Comparison of two models predicting IVF success; the effect of time trends on model 
performance. Human Reproduction 29, 57-64, doi:10.1093/humrep/det393 (2013). 
16 
Julian, L. J. Measures of anxiety: State-Trait Anxiety Inventory (STAI), Beck Anxiety Inventory (BAI), and Hospital 
Anxiety and Depression Scale-Anxiety (HADS-A). Arthritis care & research 63 Suppl 11, S467-S472, 
doi:10.1002/acr.20561 (2011). 
17 
Spielberger, C. & Sydeman, S. State Trait Anxiety Inventory and State-Trait Anger Expression Inventory, The Use of 
Psychological Tests for Treatment Planning and Outcome Assessment. Edited by Maruish ME. Hillsdale, LEA, 292-
321 (1994). 

12 
 
18 
Pook, M. & Krause, W. Stress reduction in male infertility patients: a randomized, controlled trial. Fertil Steril 83, 
68-73, doi:10.1016/j.fertnstert.2004.06.053 (2005). 
19 
Gameiro, S., Verhaak, C. M., Kremer, J. A. & Boivin, J. Why we should talk about compliance with assisted 
reproductive technologies (ART): a systematic review and meta-analysis of ART compliance rates. Hum Reprod 
Update 19, 124-135, doi:10.1093/humupd/dms045 (2013). 
20 
Boivin, J. et al. Tackling burden in ART: an integrated approach for medical staff. Hum Reprod 27, 941-950, 
doi:10.1093/humrep/der467 (2012). 
21 
CHR.L.RÜMKE. Betrouwbaarheidsintervallen. Ned Tijdschr Geneeskd, 133:2013-2015 (1989). 
22 
Campbell, M. J. Statistics at Square One. The BMJ (1997). 
23 
Hendriks, S., Peeraer, K., Bos, H., Repping, S. & Dancet, E. A. F. The importance of genetic parenthood for infertile 
men and women. Hum Reprod 32, 2076-2087, doi:10.1093/humrep/dex256 (2017). 
24 
Kenny, D. A., Kashy, D. A. & Cook, W. L. Dyadic data analysis.  (Guilford, 2006). 

13 
 
12. Appendices 
Appendix 1: Questionnaire on IVF-live birth rates expected by patients 
Your gynaecologist told you which success rates he/she expects in your case but we are interested in your expected 
IVF-live birth rate. 
What, do you think, is the chance that you or your partner will deliver after all the embryo transfers of your current 
IVF/ICSI-cycle?  
This includes both the current fresh embryo transfer and, in case embryos have been frozen, subsequent frozen 
embryo transfers. 
 
(Please indicate your response with a ‘X’ on the bar below, the arrows below explain the meaning of some possible 
answers) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
       0 
      10 
      20 
     30 
      40 
     50 
    60 
    70 
   80 
  90 
 100 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
The chance that my 
partner and I are 
having a baby after 
all embryo transfers 
from 
our 
current 
IVF/ICSI-cycle is equal 
to the chance that my 
partner and I are not 
 pregnant  
I am certain that my 
partner and I will 
have a baby after 
this embryo transfer 
I am certain that 
my partner and I 
will not have a 
baby 
after 
all 
embryo transfers 
from our current 
IVF/ICSI-cycle 

14 
 
Appendix 2: LOT-R questionnaire on general optimism (Scheier et al, 1994) 
 
Please be as honest and accurate as you can throughout. Try not to let your response to one statement influence 
your responses to other statements. There are no "correct" or "incorrect" answers. Answer according to your own 
feelings, rather than how you think "most people" would answer. 
 
 
In uncertain times, I usually expect the best. 
o 
I agree a lot  
o 
I agree a little  
o 
I neither agree nor disagree  
o 
I disagree a little  
o 
I disagree a lot  
 
It's easy for me to relax.  
o 
I agree a lot  
o 
I agree a little  
o 
I neither agree nor disagree  
o 
I disagree a little  
o 
I disagree a lot  
 
If something can go wrong for me, it will. 
o 
I agree a lot  
o 
I agree a little  
o 
I neither agree nor disagree  
o 
I disagree a little  
o 
I disagree a lot  
 
I'm always optimistic about my future.  
o 
I agree a lot  
o 
I agree a little  
o 
I neither agree nor disagree  
o 
I disagree a little  
o 
I disagree a lot  
 
I enjoy my friends a lot.  
o 
I agree a lot  
o 
I agree a little  
o 
I neither agree nor disagree  
o 
I disagree a little  
o 
I disagree a lot  
 
 
 
 
 
It's important for me to keep busy.  
o 
I agree a lot  
o 
I agree a little  
o 
I neither agree nor disagree  
o 
I disagree a little  
o 
I disagree a lot  
 
I hardly ever expect things to go my way. 
o 
I agree a lot  
o 
I agree a little  
o 
I neither agree nor disagree  
o 
I disagree a little  
o 
I disagree a lot  
 
I don't get upset too easily.  
o 
I agree a lot  
o 
I agree a little  
o 
I neither agree nor disagree  
o 
I disagree a little  
o 
I disagree a lot 
 
I rarely count on good things happening to me.  
o 
I agree a lot  
o 
I agree a little  
o 
I neither agree nor disagree  
o 
I disagree a little  
o 
I disagree a lot  
 
Overall, I expect more good things to happen to me 
than bad.  
o 
I agree a lot  
o 
I agree a little  
o 
I neither agree nor disagree  
o 
I disagree a little  
o 
I disagree a lot

15 
 
Appendix 3: the STAI-state questionnaire on state anxiety 
 
A number of statements which people have used to describe themselves are given below. Read each statement 
and then circle the appropriate number to the right of the statement to indicate how you feel right now, that 
is, at this moment. There are no right or wrong answers. Do not spend too much time on any one statement 
but give the answer which seems to describe your present feelings best. 
 
 
 
Not at all 
Somewhat  
Moderately so  
Very much so  
I feel calm 
      ☐ 
☐ 
☐ 
☐ 
I feel secure 
☐ 
☐ 
☐ 
☐ 
I am tense 
☐ 
☐ 
☐ 
☐ 
I feel strained 
☐ 
☐ 
☐ 
☐ 
I feel at ease 
☐ 
☐ 
☐ 
☐ 
I feel upset 
☐ 
☐ 
☐ 
☐ 
 am presently worrying over 
possible misfortunes 
☐ 
☐ 
☐ 
☐ 
I feel satisfied 
☐ 
☐ 
☐ 
☐ 
I feel frightened 
☐ 
☐ 
☐ 
☐ 
I feel comfortable 
☐ 
☐ 
☐ 
☐ 
I feel self-confident 
☐ 
☐ 
☐ 
☐ 
I feel nervous 
☐ 
☐ 
☐ 
☐ 
I am jittery 
☐ 
☐ 
☐ 
☐ 
I feel indecisive 
☐ 
☐ 
☐ 
☐ 
I am relaxed 
☐ 
☐ 
☐ 
☐ 
I feel content 
☐ 
☐ 
☐ 
☐ 
I am worried 
☐ 
☐ 
☐ 
☐ 
I feel confused 
☐ 
☐ 
☐ 
☐ 
I feel steady 
☐ 
☐ 
☐ 
☐ 
I feel pleasant 
☐ 
☐ 
☐ 
☐ 

16 
 
Appendix 4: IDS questionnaire on infertility specific distress (Pook&Krause, 2005) 
 
This questionnaire deals with your distress due to your (couple) infertility. Please indicate what applies best to 
you at this moment in time. 
 
 
 
Not at all 
A little 
Somewhat 
A lot 
Very much 
1 
To which extend are you distressed 
due to the last menstruation (and 
therefore no pregnancy)? 
☐ 
☐ 
☐ 
☐ 
☐ 
2 
To which extend are you distressed 
due to your infertility as a whole? 
☐ 
☐ 
☐ 
☐ 
☐ 
3 
To which extend is having a child 
important to you? 
☐ 
☐ 
☐ 
☐ 
☐ 
4 
To which extend do you appraise 
your infertility as a challenge? 
☐ 
☐ 
☐ 
☐ 
☐ 
5 
To which extend do you appraise 
your infertility as a threat? 
☐ 
☐ 
☐ 
☐ 
☐ 
6 
To which extend do you feel helpless 
due to your infertility? 
☐ 
☐ 
☐ 
☐ 
☐ 
7 
How often do you think of your 
infertility? 
☐ 
☐ 
☐ 
☐ 
☐ 
8 
How big is your desire to have a 
child?  
☐ 
☐ 
☐ 
☐ 
☐ 
 
 
 
 

17 
 
Appendix 5: Document with personalized information given at the time of embryo transfer to patients in the 
intervention group  
 

18 
 
Appendix 6: LUFC embryo quality rating  
 
LUFC-embryo rating based on embryo scoring at day three* or day five 
 
 Reduced quality 
Reasonable quality 
Good quality 
Top quality 
 
 
 
 
 
 
Day three 
<6 cells 
>3 fragmentation 
 
600 - 601 - 610 - 611 - 620 - 621 602 - 
612 - 622  
722 - 822 - 922 - 1022 
 
720 - 721 - 702 - 712 
820 - 821 - 802 - 812 
920 - 921 - 902 - 912 
1000 - 1001 - 1010 - 1011  1020 1021 - 
1002 - 1012 
700 - 701 - 710 – 711 
800 - 801 - 810 – 811 
900 - 901 - 910 – 911 
M 
Day five 
Morula or less 
Very early blastocyst 
Early blastocyst 
Expanding blastocyst 
Expanded blastocyst 
Hatching blastocyst 
Hatched blastocyst 
 
*The LUFC day three embryo scoring includes three digits: 
 
The first number indicates number of cells.  
 
The second number indicates degree of fragmentation (i.e. 0= no; 1< 10 %; 2= 10-25%; 3= 25-50%; 4>50%).  
 
The third number indicates symmetry of cells: (0= symmetric; 1= minor asymmetry; 2= asymmetric as ≥ 50% difference in size between cells) 

19 
 
Appendix 7: The thirteen factors which will be taken into account by the prognostic model 8,9  
 
The prognostic model takes account of the following thirteen factors:   
- 
Female age 
 
- 
duration of infertility 
 
- 
previous ongoing live birth 
 
 
- 
male subfertility  
- 
diminished ovarian reserve 
 
- 
endometriosis 
 
- 
basal FSH 
 
 
- 
number of failed IVF cycles 
 
 
- 
fertilization in the previous IVF-cycle 
 
 
- 
number of embryos in the current IVF-cycle  
- 
mean morphological score per day 3 embryo in the current IVF-cycle 
- 
presence of 8-cell embryos on day 3 in the current IVF-cycle  
- 
presence of morulae on day 3 in the current IVF-cycle 
 
The relative weight of the variables included in the Adapted van Loendersloot model  
Variables 
Background coding 
binary variabels 
Adapted model 
Beta 
Standard Error 
P 
Intercept 
 
1.796 
16.225 
0.912 
Couple characteristics 
Age 
- 
0.023 
1.499 
0.988 
Age x age 
- 
0.000 
0.046 
0.998 
Age x age x age 
- 
0.000 
0.000 
0.947 
Duration of infertility (years) 
- 
-0.121 
0.060 
0.044 
Previous live birth (yes/no) 
Yes=0; No=1 
-0.061 
0.167 
0.715 
Male infertility (yes/no) 
Yes=0; No=1 
0.799 
1.164 
0.492 
Diminished ovarian reserve (yes/no) 
Yes=0; No=1 
0.250 
0.312 
0.423 
Endometriosis (yes/no) 
Yes=0; No=1 
0.265 
0.190 
0.163 
Basal FSH (IU/mL) 
- 
-0.130 
0.082 
0.114 
Number of previous failed IVF-cycles 
- 
-0.088 
0.070 
0.205 
Age x male infertility 
- 
0.028 
0.034 
0.409 
Endometriosis x Diminished ovarian reserve 
Yes=0; No=1 
-0.166 
0.544 
0.760 
 
Embryo after ovum retrieval in the previous cycle (yes/no) 
Yes=0; No=1 
0.150 
0.257 
0.559 
Current cycle 
characteristics 
Number of embryos after ovum retrieval  
- 
0.153 
0.029 
0.000 
Mean morphological score all embryos day three 
- 
-0.581 
0.100 
0.000 
Eight cell embryo on day three (yes/no) 
Yes=0; No=1 
-0.199 
0.185 
0.281 
Morulae on day three (yes/no) 
Yes=0; No=1 
-0.697 
0.456 
0.126 
De formule waarmee de prognose wordt berekend: 
Probability = ey/(1+ey) 
Met 
y = 1.796 + (0.023*Age) + (-0.121*Duration of infertility) + … + (-0.697*Morulae present on d3) 

20 
 
Appendix 8: Self-developed questionnaire on uptake and assessment of on-paper personalized feedback 
Please share your uptake and assessment of the ‘on-paper personalized feedback’ which included a photo of 
your embryo, the quality of your embryo and your personal and cycle-specific chance of a live birth. 
 
 
0 
1 
2 
3 or more  
How did you look at your on-paper 
personalized feedback? 
☐ 
☐ 
☐ 
☐ 
 
 
Definitely not 
Probably not 
Probably 
Definitely 
Would you advise your friends or family who 
go through IVF at the same clinic to ask for 
the on-paper personalized feedback? 
☐ 
☐ 
☐ 
☐ 
 
 
 

21 
 
DATA PROCESSING ANNEX (“DPA”) TO THE PROTOCOL 
Definitions: 
“Protocol” means the document entitled “Gynaecologists’ feedback on ART-Pregnancy rates: 
a randomized controlled trial” (GAP-RCT) containing the details of the academic study as 
developed by the Sponsor as approved by the relevant ethics committee. 
“Sponsor” means Universitaire Ziekenhuizen Leuven 
Participating site acts as a data processor as defined under article 4, 8) of the Regulation (EU) 
2016/679 (“Data Processor”) for the Sponsor who acts as data controller as defined under 
article 4, 7) of the Regulation (EU) 2016/679 (“Data Controller”). 
“Applicable Law”  means any applicable data protection or privacy laws, including:  
(i) 
the Regulation (EU) 2016/679 also referred as the General Data Protection Regulation 
("GDPR");  
(ii) 
other applicable laws that are similar or equivalent to or that are intended to or 
implement the laws that are identified in (a) of this definition;  
"Personal Data" means any information relating to an identified or identifiable natural person 
(‘Data Subject’), including without limitation pseudonimized information, as defined in 
Applicable Law and described in the Protocol. 
Rights and obligations: 
1) The Data Processor is instructed to process the Personal Data for the term of the Protocol and 
only for the purposes of providing the data processing tasks set out in the Protocol. 
2) The Data Processor must ensure that persons authorized to process the Personal Data have 
committed themselves to confidentiality or are under an appropriate statutory obligation of 
confidentiality. 
3) The Data Processor shall implement appropriate technical and organizational measures to 
prevent that the Personal Data processed is: 
(i) 
accidentally or unlawfully destroyed, lost or altered, 
(ii) 
disclosed or made available without authorization, or 
(iii) 
otherwise processed in violation of Applicable Law.  
4) The appropriate technical and organizational security measures must be determined with due 
regard for: 
(i) 
the current state of the art, 
(ii) 
the cost of their implementation, and 
(iii) 
the nature, scope, context and purposes of processing as well as the risk of varying 
likelihood and severity for the rights and freedoms of natural persons. 
5) The Data Processor shall upon request provide the Data Controller with sufficient information 
to enable the Data Controller to ensure that the Data Processor's obligations under this DPA 
are complied with, including ensuring that the appropriate technical and organizational security 
measures have been implemented. 
6) Taking into account the nature of the processing, the Data Processor shall assist the Data 
Controller, by means of appropriate technical and organizational measures, in fulfilling its 
obligation to respond to requests from data subjects pursuant to laws and regulations in the 
area of privacy and data protection (such as, the right of access, the right to rectification, the 
right to erasure, the right to restrict the processing, the right to data portability and the right to 
object). 
7) The Data Controller is entitled to appoint at its own cost an independent expert, reasonably 
acceptable to Data Processor, who shall have access to the Data Processor's data processing 
facilities and receive the necessary information for the sole purpose of auditing whether the 
Data Processor has implemented and maintained said technical and organizational security 
measures. The expert shall upon the Data Processor's request sign a non-disclosure agreement 
provided by the Data Processor, and treat all information obtained or received from the Data 
Processor confidentially, and may only pass on, after conferral with Data Processor, the findings 
as described under 9) (ii) below to the Data Controller. 
8) The Data Processor must give authorities who by Union or Member State law have a right to 
enter the Data Controller's or the Data Controller's processors’ facilities, or representatives of 
the authorities, access to the Data Processor's physical facilities against proper proof of identity 
and mandate, during normal business hours and upon reasonable prior written notice. 

22 
 
9) The Data Processor must without undue delay in writing notify the Data Controller about: 
(i) 
any request for disclosure of Personal Data processed under the Protocol by authorities, 
unless expressly prohibited under Union or Member State law, 
(ii) 
any  finding of (a) breach of security that results in accidental or unlawful destruction, 
loss, alteration, unauthorized disclosure of, or access to, Personal Data transmitted, 
stored or otherwise processed by the Data Processor under the Protocol, or (b) other 
failure to comply with the Data Processor's obligations, or 
(iii) 
any request for access to the Personal Data (with the exception of medical records for 
which the Data Processor is considered data controller) received directly from the data 
subjects or from third parties. 
10) Such a notification from the Data Processor to the Data Controller with regard to a breach of 
security as meant in 9) (ii)(a) above will contain at least the following information: 
(i) 
The nature of the Personal Data breach, stating the categories and (by approximation) 
the number of Data Subjects concerned, and stating the categories and (by 
approximation) the number of the personal data registers affected (datasets); 
(ii) 
The likely consequences of the Personal Data breach; 
(iii) 
A proposal for measures to be taken to address the Personal Data breach, including 
(where appropriate) measures to mitigate any possible adverse effects of such breach. 
11) The Data Processor shall document (and shall keep such documentation available for the Data 
Controller) any Personal Data breaches, including the facts related to the Personal Data breach, 
its effects and the corrective measures taken. After consulting with the Data Controller, the Data 
Processor shall take any measures needed to limit the (possible) adverse effects of Personal 
Data breaches (unless such consultation cannot be awaited due to the nature of the Personal 
Data breach). 
12) The Data Processor must promptly reasonably assist the Data Controller (with the handling of 
(a) responses to any breach of security as described in 9) (ii) above and (b) any requests from 
Data Subjects under Chapter III of the GDPR, including requests for access, rectification, 
blocking or deletion. The Data Processor must also reasonably assist the Data Controller by 
implementing appropriate technical and organizational measures for the fulfilment of the Data 
Controller's obligation to respond to such requests.  
13) The Data Processor must reasonably assist the Data Controller with meeting the other 
obligations that may be incumbent on the Data Controller according to Union or Member State 
law where the assistance of the Data Processor is implied, and where the assistance of the 
Data Processor is necessary for the Data Controller to comply with its obligations. This includes, 
but is not limited to, at the request to provide the Data Controller with all necessary information 
about an incident under 9) (ii), and all necessary information for an impact assessment in 
accordance with Article 35 and Article 36 of the GDPR.  
Subprocessor: 
14) The Data Processor may only engage a subprocessor, with prior specific or general written 
consent from the Data Controller. The Data Processor undertakes to inform the Data Controller 
of any intended changes concerning the addition or replacement of a subprocessor by providing 
a reasonable prior written notice to the Data Controller. The Data Controller may reasonably 
and in a duly substantiated manner object to the use of a subprocessor. The Data Processor 
must inform the Data Controller in writing of the discontinued use of a subprocessor. 
15) Prior to the engagement of a subprocessor, the Data Processor shall conclude a written 
agreement with the subprocessor, in which at least the same data protection obligations as set 
out in this DPA shall be imposed on the subprocessor, including obligations to implement 
appropriate technical and organizational measures and to ensure that the transfer of Personal 
Data is done in such a manner that the processing will meet the requirements of the Applicable 
Law. 
16) The Data Controller has the right to receive a copy of the relevant provisions of Data Processor's 
agreement  with the subprocessor related to data protection obligations. The Data Processor 
shall remain fully liable to the Data Controller for the performance of the subprocessor 
obligations under this DPA. The fact that the Data Controller has given consent to the Data 

23 
 
Processor's use of a subprocessor is without prejudice for the Data Processor's duty to comply 
with this DPA. 
 
For acknowledgment by Principal Investigator of GZA 
Prof. dr. Peter De Loecker 
 
 
______________________________________  
 
5/9/2019 
 
 
 
 
 
 
 
 
Date 
 
 
Signed on behalf of Sponsor/Data Controller (Universitaire Ziekenhuizen Leuven) 
Prof. Dr. Wim Robberecht 
 
 
______________________________________  
 
_________________________ 
 
 
 
 
 
 
 
 
Date 
 
Signed on behalf of Participating site / Data Processor  
Johanna Devroe 
 
 
______________________________________  
 
5/9/2019                                      
 
 
 
 
 
 
 
 
Date