Endometrial Scratch Investigator Meeting
Thursday 9th March2017
The Studio, Birmingham
Chair: Mostafa Metwally
Presenters
Mostafa Metwally (MM)Sheffield Teaching Hospitals
Robin Chatters (RC)University of Sheffield
Clare Pye (CP)Sheffield Teaching Hospitals
Liz Taylor (LT)Sheffield Teaching Hospitals
Kirsty Pemberton (KP)University of Sheffield
Item / Discussion1. / Screening and consent
Q:What is the definition of a screened patient (open discussion)
It was agreed at what point a patient would be considered screened, and data entered into the database screening log. The process leading to a screened patient would be as follows:
- Review the medical notes.
- Check the patient meets the following criteria – correct age, first IVF cycle, ovulatory and previous surgery not an implication.
- Send a Patient Information Sheet.
Q:Do we need to seek HFEA consent to disclosure prior to recruiting a woman into the trial?
MMNo. The HEFA was consulted and it is not required.
Q:Can we send a letter for screening even if they have said no to contact research on the HFEA forms?
MM/LTYes as this relates to HFEA information.
Q:Can the video be viewed on mobile phones?
CP Yes.
Q:Can the Patient Information Leaflet indicate that the video is available on You Tube?
CP Yes, We will also arrange to have the link added to the PIS.
NOTE: The trial team will amend Patient Information Leaflet and posters to include video link.
Q:Can the video be displayed on screens for patients to view in waiting room areas?
CP No, the video should only be shown to the relevant patient population via the fertility unit website.
Q:Is it possible to include site contact details on the E-Freeze/Scratch joint information sheet?
CP No, there is no approval for this. Site contact details can be included on an email with the joint information sheet attached, or sent in the post along with the joint information sheet.
2. / Patient recruitment and eligibility
Q: How is the study generally received by a patient when first discussed?
LT Initially, very well received, particularly if the patient has already received information prior to the clinic visit in the post or via email.
Q:Do patients read the information you have sent them before attending clinic?
LTPatients are asked if they have read and understood the information. Patients are usually happy for the trial to be summarised. Video is an excellent tool for recruitment and should be encouraged.
Q: Is there a time period that would be considered reasonable for when a patient has a Chlamydia test?
MM Use clinical judgement and refer to NICE guidelines about infections.
Q:Group discussion around surgery/trauma to the endometrium following EVAC for miscarriage etc.. MM clarified that; Surgical intervention is not an exclusion criteria unless the clinician suspects Asherman syndrome so clinicians need to exercise their own clinical judgement.
Q:Can a patient be included in another study once they are pregnant?
CP Consider the inclusion and exclusion criteria in forthcoming studies.
Note: From a PPI perspective, it was thought a patient would prefer to take part in only one study. This was because of the quantity of paperwork involved, but ultimately participation is the patients decision
Q:Does it have to be a pipelle to perform the Endometrial Scratch procedure?
MMNo, use whatever device you use locally but record it in the medical notes and database
Q:If you were unable to perform the scratch as the patient was unable to tolerate the procedure or you were unable to pass the catheter through the cervical os could the scratch be performed again?
MM Yes, If you have not scratched the patient because it couldn’t be performed then it can be re-arranged but document this in the medical notes.
Q:Should patients with PCO morphology be excluded?
MM Look at other criteria and risk factors, and use clinical judgement.
Q:What should we do if a patient over responds to stimulation therapy
Manage as clinically appropriate. In relation to the study; If all embryos are frozen then this would be classed as a failed cycle in the intention to treat analysis but will be accounted for in the per protocol analysis and therefore the patient should remain in the study and be followed up as per routine study procedures.
Q:Is Adenomiosis an exclusion criteria?
MM No
Q:If patient is randomised to treatment as usual can she be re-randomised?
MM No. Patient can only be entered into the trial once.
Q: Is a hysteroscopy a reason to exclude?
MM No, This would not be classed as performing a scratch procedure. Hysteroscopy has not been shown by itself to increase pregnancy rates but it should be documented in the database.
Q: If a women is having cycle programming when should the scratch be performed?
MMIn the week proceeding FSH injections.
Q:Are patients who require interpreters excluded?
MM/CP No, but there are no extra funds/tools available in the trial to provide any extra support needed. This would need to be supported using your own trust resources currently available. If you are not able to satisfy yourself that the woman understands the study protocol using language line etc. then she should be considered unsuitable for inclusion.
3. / Follow-up of participants
Q:Is follow-up data still required if the scratch is not undertaken as per protocol?
MM Yes, women should carry on in study in the usual way; outcome measures will be followed up as usual. Data should be entered into the database to state that the scratch was not undertaken per protocol.
Q:If a patient becomes pregnant after the FER, will there still be a follow up after ten and a half months?
MM Yes, the patient is still part of the study; follow-up should be undertaken as usual.
Q:What happens if a woman is planned to have a fresh embryo transfer at consent, but the plan changes, and a Frozen Embryo Transfer is undertaken?
MM They will be included in the study and followed up as per study procedures. The only time the study ends is when follow-up is completed for a pregnancy, when a pregnancy ends, or when consent is withdrawn.
Q:It is sometimes difficult to follow up the patient following the pregnancy test. What should be done?
CP Document efforts made to contact patient even if no response. An ethically approved letter or email can be sent to the participant if contact is not possible via telephone but every effort should be made to follow-up all women.
Q: Following a positive pregnancy test, is there a form that can be sent out to patients detailing when contact will be made?
CPA form (or tool) can be created to provide support.
NOTE: The trial team prepare patient contact form for approval from ethics.
Q:Following a pregnancy test, can contact be made with the patient on email, rather than the telephone?
CP Yes once approval obtained from ethics
Q: After initial communication with a patient specifying the follow-up time points, is there a way of sending them a reminder, for example a text message or email?
CPYes once approval obtained from ethics
NOTE: The trial team will produce a patient time point reminder tool for approval by ethics.
4. / Delivery of the intervention
Q:If a patient says they have not used contraception, should the scratch still be carried out?
MM/CPIt depends on the situation but use your clinical judgement.If contraception has not been used the patient can be given the choice of whether or not to postpone the scratch. Ensure patient’s responses are documented e.g. reasons for not using contraception. If in doubt there is a risk of pregnancy, do not carry out the scratch.
Q: How should private centres deal with the costs of undertaking the endometrial scratch?
CP: Cost of the endometrial scratch process should not be transferred to private patients; this should be absorbed by the site.
5. / Data Management: Prospect guidance
Q:The NEQAS grading scheme for grading embryos is changing soon. How is that going to affect the marking?
MM We would prefer that the NEQAS grading is used so measures remain consistent in the trial.
Q:Is there the potential for confusion as to which embryo grading system is used when someone is looking at the data?
MM If you use a grading system other than NEQAS, please make it clear by making an annotation on the database.
Q:How often is the database run to check for discrepancies?
KP Every morning.
CP Advised sites to check for discrepancies every week.
Q: There are discrepancies being raised before data is available, for example before there is a date to carry out the scratch, before a pregnancy scan is due.
KP Data Management can allocate an appropriate delay to discrepancies as needed.
Q:Can spontaneous pregnancies be entered on the database?
KPYes, Data Management will amend data validation rules.
Q: Can you enter data straight into a form, and it will remove a discrepancy? Or do you have to enter the data and then go into the discrepancy log to remove the discrepancy?
KP If you enter the data into the applicable section of the eCRF that would resolve the discrepancy, at the point that the discrepancies are next run on the database that discrepancy will disappear.
Q: Can decimal places be entered on the database?
KP The database can be re-configured to include decimal places.
Q: Is there a way of checking all fields on the database have been completed for a patient?
KP The best way to check would be to access the discrepancy tool. If no discrepancies then you can assume all the data is completed.
Q:Why is the postcode an important field?
KP Data Management can review who is being lost and where from, and if other measures are needed to help recruit those participants.
Q: When entering data for AMH, follicle count/FSH, discrepancies are being raised. What can be done to resolve this if we don’t have data for all 3 questions ?
KP For some sites it is appropriate to enter data for all three but if not relevant, use the response n/a (not applicable) option.
Note: Data Management will change FSH day 2 to baseline FSH
Q: Can sites see their own top discrepancies?
KPCurrently no, but Data Management can produce for sites if helpful.
6. / Adverse events, serious adverse events and protocol non-compliances
Q: Is it a non-compliance if the baby is delivered prematurely but you don’t get the outcome until the actual EDD?
CP No.
Q: If a patient was admitted for a surgical evaporation would that be a serious adverse event?
CP Yesdue to the GCP definition of an SAE
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