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NCT07148999PHASE1, PHASE2RecruitingAccepts Healthy Volunteers

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

Urmila DIwekar

Start Date

9/23/2025

Completion Date

2/15/2026

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.

Eligibility Criteria

Age Range: 20 years to 50 years

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.

Interventions

COMBINATION_PRODUCT

Opt-IVF

OTHER

Control

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Conditions

Infertility (IVF Patients)

Locations

Positivf Fertility

Houston, Texas 77054

United States

Positivf Fertility

San Antonio, Texas 78249

United States