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

Not Applicable

Not yet recruiting

• Conditions: Infertility (IVF Patients)

• Registration Number: NCT07148999
• Lead Sponsor: Urmila DIwekar

Brief 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.

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-15
• Study First Submitted QC: 2025-08-22
• Last Update Submitted: 2025-08-22
• Study First Posted: 2025-08-29
• Last Update Posted: 2025-08-29
• Study Start: 2025-09-01
• Primary Completion: 2026-02-15
• Study Completion: 2026-02-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Total Gonadotropin Dosage	Two weeks after the start of the cycle	Total Gonadotropin Dosage for the cycle
Total Oocytes Retrieved	Two weeks after the start of the stimulation cycle	Total Oocytes Retrieved
M2 Oocytes	Two weeks after the start of the stimulation cycle	Total M2 Oocytes
Total Embryos Formed	Two weeks after the start of stimulation cycle	Total Embryos Formed
Grade A embryos/Blastocytes	Three weeks after the start of stimulation cycle	Grade A Day 3 Embryos or Grade A Day 5 Blastocytes

Secondary Outcome Measures

Name	Time	Method
Pregnancy Rates	one month after first transfer	Cycle pregnancy rate till the first transfer

Trial Locations

Locations (1)

Positivf Fertility; 🇺🇸 San Antonio, Texas, United States