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| Name | Class |
|---|---|
| Akansha Hospital and Research Institute, India | UNKNOWN |
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Aim: A Clinical trial to determine the effectiveness of using the proposed decision support tool (OPTIVF) for each patient's customized optimal drug dosage profile. This will be a two-arm (in the ratio 1:3) clinical trial involving more than 80 participants; one arm will undergo superovulation using dosages predicted by the decision support tool while the other arm has undergone current standard treatment. The investigators will compare the outcomes of the two groups of participants 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. The participants considered will include all ages, with and without PCOS, and low, average, and high responders.
This is a multi-site cohort with two arms (one arm for the intervention and one arm for the traditional approach) clinical trial involving more than 70 participants. The population size for the clinical trial was kept small because retrospective data for 170 patients is already collected each for comparing the two arms of the trial. Further, the data for 45 patients is there from the early small clinical trial we conducted in India.
The main site for this task is the Akansha Hospital, India, and all the analysis will be carried out at the Stochastic Research site. Dr. Urmila Diwekar will be an investigator from the Stochastic Research Technologies LLC, and Dr. Nayana Patel will be an investigator from Akansha Hospital and Research Institute.
In our study, the investigators will be using the participant's age and day three serum day AMH and FSH levels to decide the starting dose for the patient's cycle. The investigators will use the first two days of data collected (Follicular size distribution, estrogen levels) for that paticipant to determine the optimal dosage profile for the entire cycle for that participant with the help of the decision support tool OPT-IVF for this intervention in the clinical trial.
Primary and secondary outcomes will be measured.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OPTIVF predicted drug dosage | Experimental | In our study, we will be using the patient's age and day three serum day AMH and FSH levels to decide the starting dose for the patient's cycle. We will use the first two days of data collected (Follicular size distribution, estrogen levels) for that patient to determine the optimal dosage profile for the entire cycle for that patient with the help of the decision support tool OPTIVF for this intervention in the clinical trial. |
|
| Traditional drug treatment | No Intervention | Patients where drug dosage is decided by the physician based on ultrasound and estrogen levels for each day of the cycle. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OPT-IVF dosage | Device | Dosage predicted for each patient by the decision support tool OPTIVF |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of follicles retrieved | follicles retrieved | At the end of cycle 1 (each cycle ranges from 10 to 12 days) |
| Number of M2s | Number of M2s retrieved | At the end of cycle 1(each cycle ranges from 10 to 12 days) |
| No. of Very Good Embryos | Grade A Embryos | At the end of cycle 1 (each cycle ranges from 10 to 12 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Pregnancy | Whether pregnancy is resulted or not | 9 to 12 days after the transfer |
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Inclusion Criteria:
Exclusion Criteria:
This is a treatment for women only
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| Name | Affiliation | Role |
|---|---|---|
| Urmila Diwekar, Ph.D. | Stochastic Research Technologies/University of Illinois at Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Akansha Hospital and Research Institute | Anand | Gujarat | 388001 | India |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31809718 | 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. | |
| 23193444 | Background | Yenkie KM, Diwekar UM, Bhalerao V. Modeling the superovulation stage in in vitro fertilization. IEEE Trans Biomed Eng. 2013 Nov;60(11):3003-8. doi: 10.1109/TBME.2012.2227742. Epub 2012 Nov 15. |
| Label | URL |
|---|---|
| description is available at http://www.stochastic-research.com/InVitroFertilization.html | View source |
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Please contact urmila@vri-custom.org for IPD.
Available now.
Please contact urmila@vri-custom.org for IPD.
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jul 20, 2022 | |
| Reset | May 30, 2023 | |
| Release | Jun 1, 2023 | |
| Reset | Feb 7, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 20, 2022 | May 30, 2023 | |||
| Jun 1, 2023 |
OPT-IVF is a decision support tool which personalizes and optimizes dosage for each patient for each cycle.
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Identity of the patient in any form is not provided.
| 25484007 | Background | Yenkie KM, Diwekar U. Uncertainty in clinical data and stochastic model for in vitro fertilization. J Theor Biol. 2015 Feb 21;367:76-85. doi: 10.1016/j.jtbi.2014.11.004. Epub 2014 Dec 4. |
| Feb 7, 2024 |