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

NCT ID: NCT05377879

Last Updated: 2022-07-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-10

Study Completion Date

2022-07-01

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.

Conditions

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IVF

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

OPT-IVF is a decision support tool which personalizes and optimizes dosage for each patient for each cycle.
Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
Identity of the patient in any form is not provided.

Study Groups

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OPTIVF predicted drug dosage

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.

Group Type EXPERIMENTAL

OPT-IVF dosage

Intervention Type DEVICE

Dosage predicted for each patient by the decision support tool OPTIVF

Traditional drug treatment

Patients where drug dosage is decided by the physician based on ultrasound and estrogen levels for each day of the cycle.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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OPT-IVF dosage

Dosage predicted for each patient by the decision support tool OPTIVF

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Women undergoing infertility treatment

Exclusion Criteria

* No male participants
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Akansha Hospital and Research Institute, India

UNKNOWN

Sponsor Role collaborator

Stochastic Research Technologies LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Urmila Diwekar, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Stochastic Research Technologies/University of Illinois at Chicago

Locations

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Akansha Hospital and Research Institute

Anand, Gujarat, India

Site Status

Countries

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India

References

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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.

Reference Type BACKGROUND
PMID: 31809718 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23193444 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25484007 (View on PubMed)

Related Links

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http://www.stochastic-research.com

description is available at http://www.stochastic-research.com/InVitroFertilization.html

Other Identifiers

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opivf-protocol-22-1

Identifier Type: -

Identifier Source: org_study_id

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