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

Urmila DIwekar

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Infertility (IVF Patients)

Treatments: Other: Control; Combination Product: Opt-IVF

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT07148999

PPOS-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: Female

Ages: 20 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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200 participants in 2 patient groups

Control

Active Comparator group

Description:

This arm will get dosage prescribed by the doctor

Treatment:

Other: Control

Opt-IVF

Experimental group

Description:

This arm patients will get dosage provided by Opt-IVF

Treatment:

Combination Product: Opt-IVF