An Advanced Decision Support Tool for Personalized Medicine for IVF Using Modeling and Optimization

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Clinical Trial to Determine the Effectiveness of Using the Proposed Decision Support Tool for Each Patient's Customized Optimal Drug Dosage Profile

Conditions
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IVF

Intervention / Treatment
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* Device: OPT-IVF dosage


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women undergoing infertility treatment Exclusion Criteria: No male participants

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: OPT-IVF is a decision support tool which personalizes and optimizes dosage for each patient for each cycle.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OPTIVF predicted drug dosage<br>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. | Device: OPT-IVF dosage<br>* Dosage predicted for each patient by the decision support tool OPTIVF<br>|
| No Intervention: Traditional drug treatment<br>Patients where drug dosage is decided by the physician based on ultrasound and estrogen levels for each day of the cycle. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pregnancy | Whether pregnancy is resulted or not | 9 to 12 days after the transfer |