The Impact of Personalized Prognostic Counseling on IVF Patient's Experience and Treatment Utilization

NCT06319573 | Recruiting

• 1 other identifier: 2305-UNIVF-070-DC
• Study Type: interventional
• Target: 366
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Infertility

Keywords

Infertile Women Undergoing IVF or ICSI; Fertility Issues; Machine Learning; Counseling

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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.

  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.

  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.

  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 Outcomes (1)

• Self-reported satisfaction related to psychological support and cost of treatment

  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 .

Study Arms (2)

Standard Counseling

ACTIVE COMPARATOR

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

Counseling Supported by Univfy® Report

EXPERIMENTAL

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

Interventions

Counseling Supported by Univfy® Report OTHER

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.

Counseling Supported by Univfy® Report

Standard Counseling OTHER

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.

Standard Counseling

Eligibility Criteria

• Age: 18 Years - 43 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients between 18-43 in age and their healthcare providers have determined that IVF treatment using the patients' own eggs is indicated.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ginefiv: lead
• Univfy Inc.: collaborator

Study Sites (2)

Ginefiv S.L

Barcelona, 08015, Spain

RECRUITING

Ginefiv S.L

Madrid, 28018, Spain

RECRUITING

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Central Study Contacts

Xinxin L Miao

CONTACT

+34930400200; x.lin@ginefiv.com

Joaquín Llácer

CONTACT

+34915197541; j.llacer@ginefiv.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2024
• First Posted: March 20, 2024
• Study Start: March 19, 2024
• Primary Completion: August 31, 2025
• Study Completion: February 28, 2026
• Last Updated: August 22, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)