Personalized IVF medication planning using the Opt‑IVF decision tool
An Advanced Decision Support Tool for Personalized Medicine for IVF Using Modeling and Optimization for PPOS
This trial will test whether a computer tool called Opt‑IVF can choose better, personalized ovarian stimulation drug doses for women having IVF than the current standard dosing.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 20 Years to 50 Years |
| Sex | Female |
| Sponsor | Stochastic Research Technologies LLC Industry-sponsored |
| Locations | 2 sites (Houston, Texas and 1 other locations) |
| Trial ID | NCT07148999 on ClinicalTrials.gov |
What this trial studies
This is a randomized, two‑arm trial enrolling just over 100 infertile women undergoing IVF at two Texas clinics. One group will receive superovulation medication doses predicted by the Opt‑IVF decision support tool, and the other group will receive the current standard dosing. Outcomes compared include number and percentage of mature follicles retrieved, total FSH and HMG dosages used, number of monitoring/testing days, total M2s, number of embryos, Grade A embryos, and Grade A blastocysts. The Opt‑IVF tool is investigational and not approved by any regulatory body, and all treatment will be provided at the participating sites as part of the research protocol.
Who should consider this trial
Good fit: Women with infertility who plan to undergo their own IVF cycles (no donor cycles) and are willing to be treated at the participating clinics are the intended participants.
Not a fit: People who are not undergoing IVF, who will use donor eggs, whose cycles are converted to IUI, or male patients will not be eligible and would not benefit from this intervention.
Why it matters
Potential benefit: If successful, the tool could reduce medication use and monitoring days while increasing the number and quality of mature eggs and embryos for patients.
How similar studies have performed: Algorithmic and model‑based dosing approaches for ovarian stimulation have shown some promise in small or preliminary studies, but this particular Opt‑IVF approach is relatively novel and not yet widely validated.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * infertile women Exclusion Criteria: All female patients who will not undergo IVF or whose cycles will be converted to IUI. Male patients will not be enrolled in this study. No donor cycles.
Where this trial is running
Houston, Texas and 1 other locations
- Positivf Fertility — Houston, Texas, United States (Recruiting)
- Positivf Fertility — San Antonio, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Paul Magarelli, M.D., Ph.D. — IVF Academy USA
- Study coordinator: Urmila Diwekar, Ph.D.
- Email: urmila@vri-custom.org
- Phone: 6308863047
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.