A new decision-support tool in a multi-center randomized trial for personalized, optimized, and simplified fertility treatment in non-PCOS patients.
Urmila Diwekar, Shyam Gupta, Anjali Gahlan...
https://pubmed.ncbi.nlm.nih.gov/39159260/Actively Recruiting
Led by Urmila DIwekar · Updated on 2025-09-29
200
Participants Needed
2
Research Sites
N/A
Total Duration
Researchers are evaluating the effectiveness of the Opt-IVF decision support tool for personalized drug dosage in women undergoing IVF treatment in the United States. This randomized clinical trial aims to compare outcomes of patients receiving dosages predicted by Opt-IVF against those receiving standard physician-prescribed dosages. The study focuses on whether the Opt-IVF tool can provide better or similar results to current treatments by assessing various fertility outcomes. The trial involves two groups one receiving dosages determined by their doctor as standard practice, and the other receiving dosages recommended by the Opt-IVF tool. The study will monitor treatment cycles and dosage profiles, comparing measures such as the number of mature follicles, total hormone dosages used, and embryo quality. This clinical trial is conducted for research purposes and the decision support tool has not been submitted for regulatory approval. Participants will be monitored closely throughout their stimulation cycles with assessments occurring two to three weeks after the start of treatment. Researchers will measure total hormone dosages, number of oocytes retrieved, mature oocytes, embryos formed, and quality of embryos. Pregnancy rates will be evaluated one month after the first embryo transfer. The trial includes over 100 infertile women undergoing IVF, with careful tracking of treatment outcomes and safety throughout the study period.
CONDITIONS
An Advanced Decision Support Tool for Personalized Medicine for IVF Using Modeling and Optimization for Provera
U
Urmila Diwekar, Ph.D.
S
Sanjay Joag, M.D., Ph.D.
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Urmila DIwekar
Lead Sponsor
IVF Academy of USA
Collaborating Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Opt‑IVF personalized dosing tool | Physician‑determined dosing (trial control) | Guideline‑informed standard dosing |
|---|---|---|---|
| What it is | A modeling‑and‑optimization decision support system that recommends personalized gonadotropin dosing | Daily gonadotropin dose chosen by a physician based on clinical judgment | Gonadotropin dosing personalized using ovarian reserve measures following guideline recommendations |
| Role in trial | Investigational arm using optimized dosing tool | Control arm with physician‑selected dosing | Represents common clinical practice outside trial |
| Primary use | Adjust daily gonadotropin dose to each patient’s characteristics | Allow physicians to set dosing based on experience and patient evaluation | Tailor dosing based on ovarian reserve markers guided by consensus guidelines |
| How it is given or performed | Decision support software recommends daily dosing schedule | Physicians set daily doses during stimulation cycle | Clinician adjusts dosing using ovarian reserve measures (e.g., AMH, AFC) per guideline advice |
| Evidence status | Effectiveness not yet established; under investigation in randomized trial | Common clinical approach without formal comparative evidence in this trial | Supported by models and consensus recommendation though high‑level RCT data limited |
| Important risks | Risks similar to standard ovarian stimulation, unknown tool‑specific risks | Standard ovarian stimulation risks | Known risk profile under guidelines for individualized dosing |
| Important limitations | Effectiveness and safety results pending; tool usability and clinician uptake unknown | Subject to variability in physician experience; not standardized | Guideline recommendations are often based on low‑quality or indirect evidence |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 2 weeks per stimulation cycle
Participants undergo ovarian stimulation with dosages either optimized by the Opt-IVF tool or prescribed by their physician as part of IVF treatment.
Multiple visits during the stimulation cycle for dosage administration and monitoring
Duration - Up to 1 month after first embryo transfer
Participants are assessed for pregnancy rates and other outcomes following embryo transfer.
1 to 2 visits for follow-up assessments
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Urmila Diwekar, Shyam Gupta, Anjali Gahlan...
https://pubmed.ncbi.nlm.nih.gov/39159260/Apoorva Nisal, Urmila Diwekar, Vibha Bhalerao
https://pubmed.ncbi.nlm.nih.gov/31809718/Urmila DIwekar
Lead Sponsor
IVF Academy of USA
Collaborating Sponsor