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

NCT07148999 | Recruiting Phase 1 FDA Device

• 1 other identifier: PPOS-1
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

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.

Conditions

Infertility (IVF Patients)

Keywords

Opt-IVF

Outcome Measures

Primary Outcomes (5)

• Total Gonadotropin Dosage

  Total Gonadotropin Dosage for the cycle

  Two weeks after the start of the cycle

• Total Oocytes Retrieved

  Total Oocytes Retrieved

  Two weeks after the start of the stimulation cycle

• M2 Oocytes

  Total M2 Oocytes

  Two weeks after the start of the stimulation cycle

• Total Embryos Formed

  Total Embryos Formed

  Two weeks after the start of stimulation cycle

• Grade A embryos/Blastocytes

  Grade A Day 3 Embryos or Grade A Day 5 Blastocytes

  Three weeks after the start of stimulation cycle

Secondary Outcomes (1)

• Pregnancy Rates

  one month after first transfer

Study Arms (2)

Control

ACTIVE COMPARATOR

This arm will get dosage prescribed by the doctor

Other: Control

Opt-IVF

EXPERIMENTAL

This arm patients will get dosage provided by Opt-IVF

Combination Product: Opt-IVF

Interventions

Opt-IVF COMBINATION_PRODUCT

Opt-IVF provides optimized dosage profile for each patient

Opt-IVF

Control OTHER

Physicians will decide the dosage for each day for patients

Control

Eligibility Criteria

• Age: 20 Years - 50 Years
• Gender Eligibility Details: This treatment is for women undergoing IVF
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• infertile women

You may not qualify if:

• 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.

Sponsors & Collaborators

• Urmila DIwekar: lead
• IVF Academy of USA: collaborator
• Positivf Fertility: collaborator

Study Sites (2)

Positivf Fertility

Houston, Texas, 77054, United States

RECRUITING

Positivf Fertility

San Antonio, Texas, 78249, United States

RECRUITING

Related Publications (3)

• 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

  BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

Related Links

• all clinical publications are available here

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Paul Magarelli, M.D., Ph.D.

  IVF Academy USA

  PRINCIPAL INVESTIGATOR

• Francesco Arredondo, MD, Ph.D.

  Positivf Fertility

  STUDY DIRECTOR

Central Study Contacts

Urmila Diwekar, Ph.D.

CONTACT

6308863047; urmila@vri-custom.org

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

CONTACT

6305014451; sanjay@opt-ivf.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: President

Model Details: The primary protocol used in this trial is a progesterone-primed ovarian stimulation (PPOS). This is a multi-site cohort with two arms (one arm for the intervention and one arm for the traditional approach), a randomized clinical trial involving more than 100 patients. The clinical trial will be registered on ClinicalTrials.gov. It is a parallel trial with a 1:1 allocation. A Simple Randomization method will assign patients to the intervention and control groups using a lottery method. The generation of random sequences will be carried out by Dr. Diwekar, who will not be involved in the clinical administration of the trial. The patients will be registered and assigned to different groups separately at each center. The allocation will be masked until participants are ready to receive the intervention. An administrator, who will not be a clinical investigator, will allocate a participant to one arm using the random sequences generated prior to the trial. The clinicians, participants,

Study Record Dates

• First Submitted: August 15, 2025
• First Posted: August 29, 2025
• Study Start: September 23, 2025
• Primary Completion: February 15, 2026
• Study Completion: February 15, 2026
• Last Updated: September 29, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: After completion of the trial
• Access Criteria: by contacting Dr. Diwekar

Locations

US (2)