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NCT Number: NCT07148999

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

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.

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Key information

Age range

20 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Positivf Fertility, Houston, Texas, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Opt-IVF

Combination Product

Opt-IVF provides optimized dosage profile for each patient

Control

Other

Physicians will decide the dosage for each day for patients

Primary outcomes

  1. Total Gonadotropin Dosage

    Time frame: Two weeks after the start of the cycle

    Total Gonadotropin Dosage for the cycle

  2. Total Oocytes Retrieved

    Time frame: Two weeks after the start of the stimulation cycle

    Total Oocytes Retrieved

  3. M2 Oocytes

    Time frame: Two weeks after the start of the stimulation cycle

    Total M2 Oocytes

  4. Total Embryos Formed

    Time frame: Two weeks after the start of stimulation cycle

    Total Embryos Formed

  5. Grade A embryos/Blastocytes

    Time frame: Three weeks after the start of stimulation cycle

    Grade A Day 3 Embryos or Grade A Day 5 Blastocytes

Secondary outcomes

  1. Pregnancy Rates

    Time frame: one month after first transfer

    Cycle pregnancy rate till the first transfer

Study contacts

Contact information is provided by the study sponsor or research team.

Sanjay Joag, M.D., Ph.D.

CONTACT

[email protected]

6305014451

Urmila Diwekar, Ph.D.

CONTACT

[email protected]

6308863047

Sponsors and collaborators

Lead sponsor

Urmila DIwekar

Industry

Collaborators

  • IVF Academy of USA
  • Positivf Fertility

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 29, 2025
Registry last updated
Sep 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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