Infertility (IVF Patients)
Conditions
Keywords
Opt-IVF
Brief summary
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.
Detailed description
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.
Interventions
COMBINATION_PRODUCTOpt-IVF
Opt-IVF provides optimized dosage profile for each patient
OTHERControl
Physicians will decide the dosage for each day for patients
Sponsors
IVF Academy of USA
Positivf Fertility
Urmila DIwekar
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention model description
The primary protocol used in this trial is a progesterone-primed ovarian stimulation (PPOS). This is a multi-site cohort with two arms (one arm for the intervention and one arm for the traditional approach), a randomized clinical trial involving more than 100 patients. The clinical trial will be registered on ClinicalTrials.gov. It is a parallel trial with a 1:1 allocation. A Simple Randomization method will assign patients to the intervention and control groups using a lottery method. The generation of random sequences will be carried out by Dr. Diwekar, who will not be involved in the clinical administration of the trial. The patients will be registered and assigned to different groups separately at each center. The allocation will be masked until participants are ready to receive the intervention. An administrator, who will not be a clinical investigator, will allocate a participant to one arm using the random sequences generated prior to the trial. The clinicians, participants,
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* infertile women
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Gonadotropin Dosage | Two weeks after the start of the cycle | Total Gonadotropin Dosage for the cycle |
| Total Oocytes Retrieved | Two weeks after the start of the stimulation cycle | Total Oocytes Retrieved |
| M2 Oocytes | Two weeks after the start of the stimulation cycle | Total M2 Oocytes |
| Total Embryos Formed | Two weeks after the start of stimulation cycle | Total Embryos Formed |
| Grade A embryos/Blastocytes | Three weeks after the start of stimulation cycle | Grade A Day 3 Embryos or Grade A Day 5 Blastocytes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pregnancy Rates | one month after first transfer | Cycle pregnancy rate till the first transfer |
Countries
United States
Contacts
Primary ContactUrmila Diwekar, Ph.D.
Backup ContactSanjay Joag, M.D., Ph.D.
Outcome results
None listed