RecruitingNot Applicable

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

Spain366 participantsStarted 2024-03-19

Plain-language 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.

Who can participate

Age range

18 Years – 43 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Treatment utilization (conversion) rate in the two groups

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: 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 .

Trial details

NCT IDNCT06319573

SponsorGinefiv

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-08-31

Contact for this trial

Xinxin L Miao

+34930400200 x.lin@ginefiv.com

View on ClinicalTrials.gov More Infertility trials

Who can participate

Age range

18 Years – 43 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Treatment utilization (conversion) rate in the two groups

Timeframe: 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

Timeframe: 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

Retention Rate

Timeframe: 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

Timeframe: 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 .