Overview
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.
Description
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
- 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,
- 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.
Eligibility
Inclusion Criteria:
- Patients between 18-39.9 in age and their healthcare providers have determined that IVF treatment using the patients' own eggs is indicated.
Exclusion Criteria:specific to this study only (these are not contraindications to using
the Univfy® PreIVF Report):
- 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
Patients with contraindications to receiving the Univfy® PreIVF Report For Patients Under
40 Using Their Own Eggs. Those contraindications are:
- Patients who are perimenopausal or menopausal
- Patients who have very poor IVF results in the past, including:
- extremely poor oocyte/embryo quality, no embryos to transfer,
- no euploid embryos on PGT-A, no blastocysts in extended culture