Opt-IVF
Combination ProductOpt-IVF provides optimized dosage profile for each patient
NCT Number: NCT07148999
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.
Interested in participating?
Request Info20 year–50 year
Female
Interventional
Phase 1 / Phase 2
Positivf Fertility, Houston, Texas, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Opt-IVF provides optimized dosage profile for each patient
Physicians will decide the dosage for each day for patients
Time frame: Two weeks after the start of the cycle
Total Gonadotropin Dosage for the cycle
Time frame: Two weeks after the start of the stimulation cycle
Total Oocytes Retrieved
Time frame: Two weeks after the start of the stimulation cycle
Total M2 Oocytes
Time frame: Two weeks after the start of stimulation cycle
Total Embryos Formed
Time frame: Three weeks after the start of stimulation cycle
Grade A Day 3 Embryos or Grade A Day 5 Blastocytes
Time frame: one month after first transfer
Cycle pregnancy rate till the first transfer
Contact information is provided by the study sponsor or research team.
Sanjay Joag, M.D., Ph.D.
CONTACT
Urmila Diwekar, Ph.D.
CONTACT
Urmila DIwekar
Industry
An Advanced Decision Support Tool for Personalized Medicine for IVF Using Modeling and Optimization for PPOS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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