Menu
Recruiting NCT07148999

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

Phase I / Phase II Interventional Infertility (IVF Patients)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Opt-IVF, Control.
Who it may be relevant to
Registry conditions: Infertility (IVF Patients). Basic parameters: 20 years — 50 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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

Primary outcome measures

  • Total Gonadotropin Dosage [Time frame: Two weeks after the start of the cycle]
  • Total Oocytes Retrieved [Time frame: Two weeks after the start of the stimulation cycle]
  • M2 Oocytes [Time frame: Two weeks after the start of the stimulation cycle]
  • Total Embryos Formed [Time frame: Two weeks after the start of stimulation cycle]
  • Grade A embryos/Blastocytes [Time frame: Three weeks after the start of stimulation cycle]
Secondary outcome measures (1)
  • Pregnancy Rates [Time frame: one month after first transfer]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

United States · 2 centers
  • Positivf Fertility — Houston
  • Positivf Fertility — San Antonio

Publications

  • Diwekar et al., A multicenter randomized clinical trial with a novel decision support tool to improve IVF success, Reproduction and Fertility, 6(3), e250004, 2025.DOI: https://doi.org/10.1530/RAF-25-0004
  • Diwekar U, Gupta S, Gahlan A, Hota S, Murdia K, Murdia N, Chandra V, Bhoi N, Joag S. A new decision-support tool in a multi-center randomized trial for personalized, optimized, and simplified fertility treatment in non-PCOS patients. Reprod Fertil. 2024 Sep 16;5(3):e240013. doi: 10.1530/RAF-24-0013. Print 2024 Jul 1. PMID 39159260
  • Nisal A, Diwekar U, Bhalerao V. Personalized medicine for in vitro fertilization procedure using modeling and optimal control. J Theor Biol. 2020 Feb 21;487:110105. doi: 10.1016/j.jtbi.2019.110105. Epub 2019 Dec 3. PMID 31809718

Identifiers

NCT: NCT07148999 · PPOS-1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗