The Impact of Personalized Prognostic Counseling on IVF Patient's Experience and Treatment Utilization
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Counseling Supported by Univfy® Report, Standard Counseling.
- Who it may be relevant to
- Registry conditions: Infertility. Basic parameters: 18 years — 43 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Evaluation of in Vitro Fertilisation Patients' Experience With a Personalized Prognostic Counseling Strategy and Its Impact on Treatment Utilization and Discontinuation
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.
Detailed 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 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.
Interventions
- 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. - Other Standard Counseling
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.
Primary outcome measures
- Treatment utilization (conversion) rate in 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 [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 [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 [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 [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 .]
Secondary outcome measures (1)
- Self-reported satisfaction related to psychological support and cost of 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 .]
Eligibility criteria
Inclusion criteria
- Patients between 18-43 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Other
Study locations
Spain · 2 centers
- Ginefiv S.L — Barcelona
- Ginefiv S.L — Madrid
Identifiers
NCT: NCT06319573 · 2305-UNIVF-070-DC