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/39159260Actively Recruiting
Phase 1
Phase 2
Age: 20Years - 50Years
FEMALE
Healthy Volunteers
ID07148999
An Advanced Decision Support Tool for Personalized Medicine for IVF Using Modeling and Optimization for PPOS
Led by Urmila DIwekar · Updated on 2025-09-29
200
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
U
Urmila DIwekar
Lead Sponsor
I
IVF Academy of USA
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Brief Title
An Advanced Decision Support Tool for Personalized Medicine for IVF Using Modeling and Optimization for Provera
Who Can Participate
Age: 20Years - 50Years
FEMALE
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Infertile women
- Age between 20 and 50 years
- Planning to undergo IVF treatment
- No donor egg cycles
You will not qualify if you...
- Male patients
- Patients not undergoing IVF
- Patients whose cycles will be converted to intrauterine insemination (IUI)
- Donor egg cycles
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
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
Follow-up
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
Trial Site Locations
Total: 2 locations
1
Positivf Fertility
Houston, Texas, United States, 77054
Actively Recruiting
2
Positivf Fertility
San Antonio, Texas, United States, 78249
Actively Recruiting
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Research Team
U
Urmila Diwekar, Ph.D.
S
Sanjay Joag, M.D., Ph.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Personalized medicine for in vitro fertilization procedure using modeling and optimal control.
Apoorva Nisal, Urmila Diwekar, Vibha Bhalerao
https://pubmed.ncbi.nlm.nih.gov/31809718