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:
IUI and IVF treatment utilization (conversion) rates in the two groups
Responses to the anonymous online questionnaire in the two groups
Retention rate in the two groups
Time to pregnancy
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)
Age
AMH levels
BMI values
clinical diagnoses such as male factor, poor ovarian response/reserve, tuba! factor,
uterine factor, endometriosis, etc.
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.