The Impact of Personalized Prognostic Counseling on IVF Patient's Experience and Treatment Utilization
ConditionInfertility
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-43
SponsorGinefiv
About this trial
This study will be conducted in two phases. In the first phase, research subjects will be assigned to receive standard counseling. In the second phase, research subjects will receive Univfy counseling.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients between 18-43 in age and their healthcare providers have determined that IVF treatment using the patients' own eggs is indicated.
Disqualifiers
Same sex couples
Patients undergoing DuoStim and/or PGT-M/-SR
Patients considering egg freezing rather than IVF
Patients considering the use of donor eggs or gestational carrier
Trial design
Design model
Sequential
Treatments tested in this trial
Counseling Supported by Univfy® Report
Other interventionThe intervention consists of patients being counseled with the Univfy® PreIVF report during their second consultation. They will also be asked to fill in the same anonymous online questionnaire.
Standard Counseling
Other interventionPatients in this group will be counseled as per standard care during their second consultation. They will be asked to complete an anonymous online validated questionnaire (see below) to assess their responses to the anonymous online questionnaire after consultation.
Treatment groups
366 Participants
are divided into 2 treatment groupsGroup A: Standard CounselingActive comparator 1 intervention
Group B: Counseling Supported by Univfy® ReportExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Treatment utilization (conversion) rate in the two groups
The treatment conversion rate refers to the proportion of patients who initiate IVF treatment after undergoing the initial consultation and counseling. This outcome will be compared between the two groups.
Time frame
A full 12 months of follow up starting at the end of Phase 2. An interim analysis using data up to the 6 months following the end of Phase 2 will be performed .2
Patient experience responses
Research satisfaction topics related to counseling about IVF treatment and IVF treatment success probability on a scale of 1-5: Consultation met expectations Satisfied with explanation of consent Felt listened to by your physician Satisfied with physician's explanation of treatment needed Satisfied with physician's explanation of medications needed and possible side effects Satisfied with clarity of physician's explanation of probability of IVF success Satisfied with material given to explain probability of IVF success Your physician's clarity and honesty about your probability of IVF success Do you think receiving information about your chances of treatment failure will help you to cope with the whole treatment.
Time frame
A full 12 months of follow up starting at the end of Phase 2. An interim analysis using data up to the 6 months following the end of Phase 2 will be performed3
Validation of Univfy prediction upon CLBdR
This outcome assesses the accuracy of the Univfy model's predictions regarding cumulative live birth delivery rate (CLBdR). It compares the predicted CLBdR for each patient group with their actual CLBdR after completing the treatment cycle.
Time frame
A full 12 months of follow up starting at the end of Phase 2. An interim analysis using data (e.g. positive serum HCG, fetal sac on ultrasound, fetal heart on ultrasound) up to the 6 months following the end of Phase 2 will be performed . Study follow up4
Retention Rate
This outcome measures the proportion of patients who continue with IVF treatment attempts after facing an unsuccessful first cycle.
Time frame
A full 12 months of follow up starting at the end of Phase 2. An interim analysis using data up to the 6 months following the end of Phase 2 will be performedSecondary outcomes
1
Self-reported satisfaction related to psychological support and cost of treatment
Research satisfaction topics based on patient's self-reported satisfaction related to psychological support and cost of treatment on a scale of 1-5: Satisfied with the level of attention given to your emotional needs Satisfied with the explanation given on the cost of treatment Satisfied with the time of the first visit Satisfied with the way your physician proposed psychological support Do you believe that psychological support is important after being diagnosed with infertility
Time frame
A full 12 months of follow up starting at the end of Phase 2. An interim analysis using data up to the 6 months following the end of Phase 2 will be performed .Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Ginefiv
Lead sponsor
Univfy Inc.
Collaborator
Source ClinicalTrials.gov