NCT07148999

An Advanced Decision Support Tool for Personalized Medicine for IVF Using Modeling and Optimization for Provera

An Advanced Decision Support Tool for Personalized Medicine for IVF Using Modeling and Optimization for PPOS

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Urmila DIwekar · Industry
• Sex: Female
• Age: 20 Years – 50 Years
• Healthy volunteers: Accepted

Summary

A clinical trial will determine the effectiveness of using the Opt-IVF decision support tool for each patient's personalized and optimal drug dosage profile in the United States.

Detailed description

This will be a two-arm randomized clinical trial involving more than 100 patients; one arm will undergo superovulation using dosages predicted by the decision support tool, while the other will undergo the current standard treatment. The research question is whether outcomes of patient dosage treatment using Opt-IVF are better or similar to the current practice. We will compare the outcomes of the two groups of patients in terms of the numbers and percentage of mature follicles retrieved at the end of each cycle, total FSH and HMG dosages used, and the number of required testing days for that cycle, total number of M2s, Number of embryos, Number of Grade A embryos and Number of Grade A blastocysts. The trial is for research purposes only. The current tool has not been submitted for any regulatory body approval.

Conditions

• Infertility (IVF Patients)

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Opt-IVF	Opt-IVF provides optimized dosage profile for each patient
OTHER	Control	Physicians will decide the dosage for each day for patients

Timeline

• Start date: 2025-09-23
• Primary completion: 2026-02-15
• Completion: 2026-02-15
• First posted: 2025-08-29
• Last updated: 2025-09-29

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study