An interventional study of Counseling Supported by Univfy® Report and Standard Counseling in Infertility, sponsored by Ginefiv. Recruiting at 2 sites in Spain. Open to female participants aged 18 Years to 43 Years. Per ClinicalTrials.gov, last updated 2024-08-22.
Sponsored by Ginefiv · Not applicable, Interventional, and Other
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.
Study period: 6 months plus 12 months follow-up. Participating centers: Ginefiv Madrid and Barcelona Inclusion / Exclusion criteria: See the Section on Inclusion and Exclusion Criteria.
In the first three months of the study, the participants (consenting patients) will be counseled as per standard care during their consultations ("Phase 1: Standard Counseling"). They will be asked to complete an anonymous online questionnaire to assess their experience after the consultation.
In the following 3 months of the study ("Phase 2: Univfy Report"), the participants (different from participants recruited in Phase 1) will instead be counseled with the Univfy PreIVF report during their initial consultation or subsequent consultations (as soon as a Univfy PreIVF report can be generated). They will be asked to complete an anonymous online questionnaire to assess their experience after the consultation.
During the following 12 months ("Phase 3: Outcomes Data Collection Period"), we will measure 1) patient experience based on patients' responses to the anonymous online questionnaire 2) IVF and intrauterine insemination (IUI) treatment utilization rates within 6 and 12 months, 3) patient retention rates after the first failed treatment attempt, 4) IUI-live birth rates and the cumulative live birth delivery rate (CLBdR, defined according to ICMART). The above metrics will be compared between participants who received conventional counseling versus those who received the Univfy report.
Outcomes:
Sub-analyses will be conducted in different patient populations (e.g., poor responders, severe male factor, the indication to PGT-A) and according to each IVF center and clinician. Here are categories defined a priori that will be used in sub-group analysis: prognostic tier, with each tier defined by the PreIVF model-predicted probability of live birth (this is the most objective way to define a sub-group)
Interim Analysis:
Interim analyses will be conducted at Month#9, Month#12, Month#15, and Month#18 to allow identification of positive results should they occur prior to the completion of Phase 2. Physicians will be blinded to the results of the analysis.
Sample size analysis:
Estimating a 15%-increase in the treatment conversion rate (from 50 to 65%) with 80% power and 5% alpha error probability, we will need at least 183 patients per group (366 in total).
Estimating a 20%-decrease in the treatment discontinuation between first, and second attempts (from 70 to 50%) with 80% power and 5% alpha error probability, we will need at least 102 patients who failed a first attempt per group (204 in total).
Univfy® products and services are protected by US Patent Number 9,458,495B2, foreign counterparts and other issued and pending patents.
2,085 studies on the registry are indexed under Infertility; 357 are open to participants now.
This study's planned enrollment of 366 is above the median of 135 across 1,412 interventional studies indexed under Infertility.
Browse Infertility studies →Ginefiv is the lead sponsor of 3 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Exclusion Criteria:specific to this study only (these are not to using the Univfy® PreIVF Report):
Patients with contraindications to receiving the Univfy® PreIVF Report For Patients Under 40 Using Their Own Eggs. Those contraindications are:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients 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.
Other: Standard Counseling
Patients in this group will be counseled with the Univfy® PreIVF report during their second consultation. They will also be asked to fill out the same anonymous online questionnaire.
Other: Counseling Supported by Univfy® Report
The 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.
Patients 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 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 .
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 performed
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 up
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 performed
Time to Pregnancy
This outcome tracks the duration it takes for a patient to achieve pregnancy after the initial and second consultation.
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 .
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 .
Plan to share: No
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Started Mar 2024 (actual). Primary completion is estimated for Aug 2025, 17 months after the start.
Of 385 non-industry interventional studies with no phase under Infertility, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 46. This study's planned 17 months is below that.
Counting every sponsor, half of 416 studies reached it within 24 months; a quarter within 10 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
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