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

NCT05377879 | Completed

• 1 other identifier: opivf-protocol-22-1
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

IVF

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Pregnancy

  9 to 12 days after the transfer

Study Arms (2)

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.

Device: OPT-IVF dosage

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.

Interventions

OPT-IVF dosage DEVICE

Dosage predicted for each patient by the decision support tool OPTIVF

OPTIVF predicted drug dosage

Eligibility Criteria

• Age: 20 Years - 50 Years
• Gender Eligibility Details: This is a treatment for women only
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women undergoing infertility treatment

You may not qualify if:

• No male participants

Sponsors & Collaborators

• Stochastic Research Technologies LLC: lead
• Akansha Hospital and Research Institute, India: collaborator

Study Sites (1)

Akansha Hospital and Research Institute

Anand, Gujarat, 388001, India

Location

Related Publications (3)

• 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.

  PMID: 31809718 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.

  PMID: 23193444 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.

  PMID: 25484007 BACKGROUND

Related Links

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

Study Officials

• Urmila Diwekar, Ph.D.

  Stochastic Research Technologies/University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Identity of the patient in any form is not provided.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: OPT-IVF is a decision support tool which personalizes and optimizes dosage for each patient for each cycle.

Study Record Dates

• First Submitted: May 4, 2022
• First Posted: May 17, 2022
• Study Start: May 10, 2022
• Primary Completion: June 30, 2022
• Study Completion: July 1, 2022
• Last Updated: July 21, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Available now.
• Access Criteria: Please contact urmila@vri-custom.org for IPD.

Locations

IN (1)