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| Name | Class |
|---|---|
| IVF Academy of USA | UNKNOWN |
| Positivf Fertility | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Active Comparator | This arm will get dosage prescribed by the doctor |
|
| Opt-IVF | Experimental | This arm patients will get dosage provided by Opt-IVF |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Opt-IVF | Combination Product | Opt-IVF provides optimized dosage profile for each patient |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Total Gonadotropin Dosage | Total Gonadotropin Dosage for the cycle | Two weeks after the start of the cycle |
| Total Oocytes Retrieved | Total Oocytes Retrieved | Two weeks after the start of the stimulation cycle |
| M2 Oocytes | Total M2 Oocytes | Two weeks after the start of the stimulation cycle |
| Total Embryos Formed | Total Embryos Formed | Two weeks after the start of stimulation cycle |
| Grade A embryos/Blastocytes | Grade A Day 3 Embryos or Grade A Day 5 Blastocytes | Three weeks after the start of stimulation cycle |
| Measure | Description | Time Frame |
|---|---|---|
| Pregnancy Rates | Cycle pregnancy rate till the first transfer | one month after first transfer |
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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.
This treatment is for women undergoing IVF
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Urmila Diwekar, Ph.D. | Contact | 6308863047 | urmila@vri-custom.org | |
| Sanjay Joag, M.D., Ph.D. | Contact | 6305014451 | sanjay@opt-ivf.com |
| Name | Affiliation | Role |
|---|---|---|
| Paul Magarelli, M.D., Ph.D. | IVF Academy USA | Principal Investigator |
| Francesco Arredondo, MD, Ph.D. | Positivf Fertility | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Positivf Fertility | Recruiting | Houston | Texas | 77054 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Diwekar et al., A multicenter randomized clinical trial with a novel decision support tool to improve IVF success, Reproduction and Fertility, 6(3), e250004, 2025.DOI: https://doi.org/10.1530/RAF-25-0004 | ||
| 39159260 | Background | Diwekar U, Gupta S, Gahlan A, Hota S, Murdia K, Murdia N, Chandra V, Bhoi N, Joag S. A new decision-support tool in a multi-center randomized trial for personalized, optimized, and simplified fertility treatment in non-PCOS patients. Reprod Fertil. 2024 Sep 16;5(3):e240013. doi: 10.1530/RAF-24-0013. Print 2024 Jul 1. | |
| 31809718 |
| Label | URL |
|---|---|
| all clinical publications are available here | View source |
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Data will be available by contacting Dr. Urmila Diwekar
After completion of the trial
by contacting Dr. Diwekar
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| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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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,
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| Control |
| Other |
Physicians will decide the dosage for each day for patients |
|
| Positivf Fertility | Recruiting | San Antonio | Texas | 78249 | United States |
|
| Background |
| Nisal A, Diwekar U, Bhalerao V. Personalized medicine for in vitro fertilization procedure using modeling and optimal control. J Theor Biol. 2020 Feb 21;487:110105. doi: 10.1016/j.jtbi.2019.110105. Epub 2019 Dec 3. |