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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
200
Positivf Fertility
Houston, Texas, United States
RECRUITINGPositivf Fertility
San Antonio, Texas, United States
RECRUITINGTotal Gonadotropin Dosage
Total Gonadotropin Dosage for the cycle
Time frame: Two weeks after the start of the cycle
Total Oocytes Retrieved
Total Oocytes Retrieved
Time frame: Two weeks after the start of the stimulation cycle
M2 Oocytes
Total M2 Oocytes
Time frame: Two weeks after the start of the stimulation cycle
Total Embryos Formed
Total Embryos Formed
Time frame: Two weeks after the start of stimulation cycle
Grade A embryos/Blastocytes
Grade A Day 3 Embryos or Grade A Day 5 Blastocytes
Time frame: Three weeks after the start of stimulation cycle
Pregnancy Rates
Cycle pregnancy rate till the first transfer
Time frame: one month after first transfer
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