Infertility (IVF Patients)Phase 1/2NCT07148999
An Advanced Decision Support Tool for Personalized Medicine for IVF Using Modeling and Optimization for Provera
A Phase 1/2 study testing Opt-IVF in people with Infertility (IVF Patients), run by Urmila DIwekar at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility (IVF Patients)
- What is being tested?
- Opt-IVF
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesUnited States
- Study dates
- 23 Sep 2025to 15 Feb 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- infertile women
Who cannot join
- 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 locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Positivf Fertility
Houston, Texas, 77054
Paul Magarelli, MD, Ph.D., 719-331-6392, pcmagarelli@gmail.com
- Recruiting
Positivf Fertility
San Antonio, Texas, 78249
Francisco Arrendendo, MD, MPh, 210-404-2229, paco@positivf.com
About this study
Official title: An Advanced Decision Support Tool for Personalized Medicine for IVF Using Modeling and Optimization for PPOS
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.
Read the 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.
- Conditions
- Infertility (IVF Patients)
- Being tested
- Opt-IVF, Control
- Keywords
- Opt-IVF
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Opt-IVFCombination product
Opt-IVF provides optimized dosage profile for each patient
ControlOther
Physicians will decide the dosage for each day for patients
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | This arm will get dosage prescribed by the doctor Receives: Other: Control |
| Opt-IVF | Experimental | This arm patients will get dosage provided by Opt-IVF Receives: Combination Product: Opt-IVF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Gonadotropin Dosage
Total Gonadotropin Dosage for the cycle
Measured: Two weeks after the start of the cycle
Total Oocytes Retrieved
Total Oocytes Retrieved
Measured: Two weeks after the start of the stimulation cycle
M2 Oocytes
Total M2 Oocytes
Measured: Two weeks after the start of the stimulation cycle
Total Embryos Formed
Total Embryos Formed
Measured: Two weeks after the start of stimulation cycle
Grade A embryos/Blastocytes
Grade A Day 3 Embryos or Grade A Day 5 Blastocytes
Measured: Three weeks after the start of stimulation cycle
Secondary outcomes (1)
Pregnancy Rates
Cycle pregnancy rate till the first transfer
Measured: one month after first transfer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2025
- Study start23 Sep 2025 (estimated)
- Primary completion15 Feb 2026 (estimated)
- Study completion15 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Infertility (IVF Patients)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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,
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Urmila DIwekar
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- IVF Academy of USA, Positivf Fertility
- Responsible party
- Sponsor-investigator, Urmila DIwekar, Stochastic Research Technologies LLC
- Investigators
- Paul Magarelli, M.D., Ph.D., Principal investigator, IVF Academy USAFrancesco Arredondo, MD, Ph.D., Study director, Positivf Fertility
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07148999
- Sponsor's protocol ID
- PPOS-1
- Status last verified
- Sep 2025
- First submitted
- 15 Aug 2025
- Last updated
- 29 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Data will be available by contacting Dr. Urmila Diwekar
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.
PubMed 39159260Nisal 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.
PubMed 31809718
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Advanced Decision Support Tool for Personalized Medicine for IVF Using Modeling and Optimization for PPOS
- ClinicalTrials.gov ID
- NCT07148999
- Acronym / sponsor ID
- PPOS-1
- Conditions
- Infertility (IVF Patients)
- Keywords
- Opt-IVF
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Urmila DIwekarIndustry (pharma, biotech, devices)
- Collaborators
- IVF Academy of USA, Positivf Fertility
- Study start
- 23 Sep 2025 (estimated)
- Primary completion
- 15 Feb 2026 (estimated)
- Study completion
- 15 Feb 2026 (estimated)
- First posted
- 29 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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,
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Other: ControlThis arm will get dosage prescribed by the doctor |
| Opt-IVF | Experimental | Combination Product: Opt-IVFThis arm patients will get dosage provided by Opt-IVF |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- infertile women
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Opt-IVFOpt-IVF provides optimized dosage profile for each patient | Combination product | Opt-IVF |
| ControlPhysicians will decide the dosage for each day for patients | Other | Control |
Primary outcome
Total Gonadotropin Dosage
Time frame: Two weeks after the start of the cycle
Total Gonadotropin Dosage for the cycle
Total Oocytes Retrieved
Time frame: Two weeks after the start of the stimulation cycle
Total Oocytes Retrieved
M2 Oocytes
Time frame: Two weeks after the start of the stimulation cycle
Total M2 Oocytes
Total Embryos Formed
Time frame: Two weeks after the start of stimulation cycle
Total Embryos Formed
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
1 secondary outcome
Pregnancy Rates
Time frame: one month after first transfer
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2025.
- BackgroundDiwekar 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: PubMed 39159260Diwekar 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.
- Background: PubMed 31809718Nisal 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.
- all clinical publications are available hereLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Data will be available by contacting Dr. Urmila Diwekar
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Paul Magarelli, M.D., Ph.D. principal investigator
IVF Academy USA
Francesco Arredondo, MD, Ph.D. study director
Positivf Fertility
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Opt-IVF in people with Infertility (IVF Patients), run by Urmila DIwekar at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Urmila Diwekar, Ph.D. (6308863047, urmila@vri-custom.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Gonadotropin Dosage (time frame: Two weeks after the start of the cycle). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07148999, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2025.