An Advanced Decision Support Tool for Personalized Medicine for IVF Using Modeling and Optimization (OPT-IVF)

July 20, 2022 updated by: Stochastic Research Technologies LLC

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Gujrat
      • Anand, Gujrat, India, 388001
        • Akansha Hospital and Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women undergoing infertility treatment

Exclusion Criteria:

  • No male participants

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Device: OPT-IVF dosage
Dosage predicted for each patient by the decision support tool OPTIVF
No Intervention: Traditional drug treatment
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?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of follicles retrieved
Time Frame: At the end of cycle 1 (each cycle ranges from 10 to 12 days)
follicles retrieved
At the end of cycle 1 (each cycle ranges from 10 to 12 days)
Number of M2s
Time Frame: At the end of cycle 1(each cycle ranges from 10 to 12 days)
Number of M2s retrieved
At the end of cycle 1(each cycle ranges from 10 to 12 days)
No. of Very Good Embryos
Time Frame: At the end of cycle 1 (each cycle ranges from 10 to 12 days)
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
Time Frame: 9 to 12 days after the transfer
Whether pregnancy is resulted or not
9 to 12 days after the transfer

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stochastic Research Technologies LLC

Collaborators

Akansha Hospital and Research Institute, India

Investigators

  • Principal Investigator: Urmila Diwekar, Ph.D., Stochastic Research Technologies/University of Illinois at Chicago

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 10, 2022

Primary Completion (Actual)

June 30, 2022

Study Completion (Actual)

July 1, 2022

Study Registration Dates

First Submitted

May 4, 2022

First Submitted That Met QC Criteria

May 11, 2022

First Posted (Actual)

May 17, 2022

Study Record Updates

Last Update Posted (Actual)

July 21, 2022

Last Update Submitted That Met QC Criteria

July 20, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • opivf-protocol-22-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Please contact urmila@vri-custom.org for IPD.

IPD Sharing Time Frame

Available now.

IPD Sharing Access Criteria

Please contact urmila@vri-custom.org for IPD.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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