Opt-IVF for Personalized Medicine for Normal Responders
The Advanced Decision Support Tool, Opt-IVF for Personalized Medicine for IVF Antagonist and Progesterone-Primed Ovarian Stimulation (PPOS) Protocol for Normal Responders
1 other identifier
interventional
100
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Oct 2026
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 28, 2026
CompletedFirst Posted
Study publicly available on registry
October 2, 2026
CompletedStudy Start
First participant enrolled
October 15, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2027
Study Completion
Last participant's last visit for all outcomes
April 30, 2027
October 2, 2026
September 1, 2026
6 months
September 28, 2026
September 28, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Total Gonadotropin dosage
Total Dosage
11 days
Secondary Outcomes (3)
M2 Oocytes
13 days
Total Embryos
15 days
Grade A Blastocysts
20 days
Study Arms (2)
Opt-IVF
EXPERIMENTALOpt-IVF 1.0 arm will receive personalized total-gonadotropin optimization predicted dosage per day
Control
ACTIVE COMPARATORThis standard-care arm will receive physician-directed dosing
Interventions
Eligibility Criteria
You may qualify if:
- Normal Responders
You may not qualify if:
- PCOS and Poor Responders
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Urmila DIwekarlead
Study Sites (1)
ABC IVF
West Palm Beach, Florida, 33407, United States
Related Publications (1)
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.
BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dr. Paul Magarelli, M.D., Ph.D.
The American Baby Company
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Masking Details
- The clinicians, participants, and outcome assessors will be blinded to treatment assignment. Only the research coordinator will be aware of the treatment assignment.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- President
Study Record Dates
First Submitted
September 28, 2026
First Posted
October 2, 2026
Study Start (Estimated)
October 15, 2026
Primary Completion (Estimated)
March 31, 2027
Study Completion (Estimated)
April 30, 2027
Last Updated
October 2, 2026
Record last verified: 2026-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- June 1, 2027
- Access Criteria
- They can contact the PI or Opt-IVF website and they will send the requested information
by contacting the PI.