An Advanced Decision Support Tool for Personalized Medicine for IVF Using Modeling and Optimization for Provera
NCT ID: NCT07148999
Last Updated: 2025-09-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
200 participants
INTERVENTIONAL
2025-09-23
2026-02-15
Brief Summary
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Detailed Description
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The trial is for research purposes only. The current tool has not been submitted for any regulatory body approval.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
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,
TREATMENT
TRIPLE
Study Groups
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Control
This arm will get dosage prescribed by the doctor
Control
Physicians will decide the dosage for each day for patients
Opt-IVF
This arm patients will get dosage provided by Opt-IVF
Opt-IVF
Opt-IVF provides optimized dosage profile for each patient
Interventions
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Opt-IVF
Opt-IVF provides optimized dosage profile for each patient
Control
Physicians will decide the dosage for each day for patients
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
20 Years
50 Years
FEMALE
Yes
Sponsors
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IVF Academy of USA
UNKNOWN
Positivf Fertility
UNKNOWN
Urmila DIwekar
INDUSTRY
Responsible Party
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Urmila DIwekar
President
Principal Investigators
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Paul Magarelli, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
IVF Academy USA
Francesco Arredondo, MD, Ph.D.
Role: STUDY_DIRECTOR
Positivf Fertility
Locations
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Positivf Fertility
Houston, Texas, United States
Positivf Fertility
San Antonio, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
Related Links
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all clinical publications are available here
Other Identifiers
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PPOS-1
Identifier Type: -
Identifier Source: org_study_id
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