IvfPhase 1/2NCT07856082
Opt-IVF for Personalized Medicine for Normal Responders
A Phase 1/2 study testing Opt-IVF in people with Ivf, run by Urmila DIwekar at 1 site in United States.
Trial summary
A clinical trial will determine the effectiveness of the Opt-IVF decision-support tool in generating personalized, optimal drug-dosage profiles for each patient in the United States. Read more about this study
- Who is it for?
- Ages 20 to 50 years, women only
- Conditions the study is for
- Ivf
- What is being tested?
- Opt-IVF
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2026to 30 Apr 2027
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Normal Responders
Who cannot join
- PCOS and Poor Responders
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
ABC IVF
West Palm Beach, Florida, 33407
Dr. Paul Magarelli, M.D., Ph.D., 630-886-3047, paul@americanbabyco.com
Dr. Sanjay Joag, M.D., Ph.D., 6305014451, sanjay@opt-iVF.com
About this study
Official title: The Advanced Decision Support Tool, Opt-IVF for Personalized Medicine for IVF Antagonist and Progesterone-Primed Ovarian Stimulation (PPOS) Protocol for Normal Responders
A clinical trial will determine the effectiveness of the Opt-IVF decision-support tool in generating personalized, optimal drug-dosage profiles for each patient 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 receive 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.
- Conditions
- Ivf
- Being tested
- Opt-IVF, control
- Keywords
- Infertility, IVF, Antagonist, PPOS
- Medical subject headings
- Long Qt Syndrome 3, Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Opt-IVFDevice
Opt-IVF predicted dosage for IVF
controlOther
Doctor prescribed dosage
| Study group | Role | What they receive |
|---|---|---|
| Opt-IVF | Experimental | Opt-IVF 1.0 arm will receive personalized total-gonadotropin optimization predicted dosage per day Receives: Device: Opt-IVF |
| Control | Active comparator | This standard-care arm will receive physician-directed dosing Receives: Other: control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Gonadotropin dosage
Total Dosage
Measured: 11 days
Secondary outcomes (3)
M2 Oocytes
M2 Oocytes
Measured: 13 days
Total Embryos
Number of Embryos
Measured: 15 days
Grade A Blastocysts
No. of Grade A blastocysts
Measured: 20 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2026
- Study start15 Oct 2026 (estimated)
- Primary completion31 Mar 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for IvfStudies 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
- This is a single-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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Urmila DIwekar
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor-investigator, Urmila DIwekar, Stochastic Research Technologies LLC
- Investigators
- Dr. Paul Magarelli, M.D., Ph.D., Principal investigator, The American Baby Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07856082
- Sponsor's protocol ID
- USTrial-2026-1
- Status last verified
- Sep 2026
- First submitted
- 28 Sep 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: by contacting the PI.
Publications
Diwekar U, Bhoi N, Gupta S, Sharma A, Hota S, Lunkad A, Arora S, Kumari S, Naik A, Batra T, Naik S, Jangid A, Kumar P, Kumar S, Joag S. A multicenter randomized clinical trial with a novel decision support tool to improve IVF success. Reproduction and Fertility. 2025 July; 6(3):-. doi: 10.1530/RAF-25-0004.
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Advanced Decision Support Tool, Opt-IVF for Personalized Medicine for IVF Antagonist and Progesterone-Primed Ovarian Stimulation (PPOS) Protocol for Normal Responders
- ClinicalTrials.gov ID
- NCT07856082
- Acronym / sponsor ID
- USTrial-2026-1
- Conditions
- Ivf
- Keywords
- Infertility, IVF, Antagonist, PPOS
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Urmila DIwekarIndustry (pharma, biotech, devices)
- Study start
- 15 Oct 2026 (estimated)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 2 Oct 2026 (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 the Opt-IVF decision-support tool in generating personalized, optimal drug-dosage profiles for each patient 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 receive 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a single-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.
| Arm | Type | Receives |
|---|---|---|
| Opt-IVF | Experimental | Device: Opt-IVFOpt-IVF 1.0 arm will receive personalized total-gonadotropin optimization predicted dosage per day |
| Control | Active comparator | Other: controlThis standard-care arm will receive physician-directed dosing |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Normal Responders
Key exclusion criteria (1 listed)
- PCOS and Poor Responders
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 predicted dosage for IVF | Device | Opt-IVF |
| controlDoctor prescribed dosage | Other | Control |
Primary outcome
Total Gonadotropin dosage
Time frame: 11 days
Total Dosage
3 secondary outcomes
M2 Oocytes
Time frame: 13 days
Total Embryos
Time frame: 15 days
Grade A Blastocysts
Time frame: 20 days
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 2 Oct 2026.
- BackgroundDiwekar U, Bhoi N, Gupta S, Sharma A, Hota S, Lunkad A, Arora S, Kumari S, Naik A, Batra T, Naik S, Jangid A, Kumar P, Kumar S, Joag S. A multicenter randomized clinical trial with a novel decision support tool to improve IVF success. Reproduction and Fertility. 2025 July; 6(3):-. doi: 10.1530/RAF-25-0004.
- Individual participant dataSharing planned: Yes. by contacting the PI.
Related trials for Ivf
Recruiting
Trigger Timing in Ovarian Stimulations
IVF Outcome
Recruiting
225 IU Versus 300 IU Starting FSH Dose in PPOS for Good-Prognosis Women
Infertility (IVF Patients), Infertility Assisted Reproductive Technology
Recruiting
The Effects of Carnitine Supplementation on Oocytes in Women Undergoing IVF Process
Infertility (IVF Patients)
RecruitingPhase 4
Study of G-CSF for DOR in Patients Undergoing IVF
Diminished Ovarian Reserve, IVF
RecruitingObservational study
Machine-Learning Prediction of Pregnancy Outcomes After Assisted Reproductive Treatments
IVF Outcomes, Prediction Models
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.
Dr. Paul Magarelli, M.D., Ph.D. principal investigator
The American Baby Company
1 site 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 Ivf, run by Urmila DIwekar at 1 site 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 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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@opt-ivf.com), 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: 11 days). 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 NCT07856082, which also lists 1 linked publication.
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 2 Oct 2026; AzTrials last refreshed its copy on 3 Nov 2026.