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

IVF Clinical Trial

— OPT-IVF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05377879
• Other study ID #: opivf-protocol-22-1
• Status: Completed
• Phase: N/A
• Start date: May 10, 2022
• Est. completion date: July 1, 2022

Study information

• Verified date: July 2022
• Source: Stochastic Research Technologies LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: July 1, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 50 Years

Eligibility

Inclusion Criteria:

• Women undergoing infertility treatment

Exclusion Criteria:

• No male participants

Related Conditions & MeSH terms

• IVF

Intervention

Device:
• OPT-IVF dosage
Dosage predicted for each patient by the decision support tool OPTIVF

Locations

Country	Name	City	State
India	Akansha Hospital and Research Institute	Anand	Gujrat

Sponsors (2)

Lead Sponsor	Collaborator
Stochastic Research Technologies LLC	Akansha Hospital and Research Institute, India

Country where clinical trial is conducted

India, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of follicles retrieved	follicles retrieved	At the end of cycle 1 (each cycle ranges from 10 to 12 days)
Primary	Number of M2s	Number of M2s retrieved	At the end of cycle 1(each cycle ranges from 10 to 12 days)
Primary	No. of Very Good Embryos	Grade A Embryos	At the end of cycle 1 (each cycle ranges from 10 to 12 days)
Secondary	Pregnancy	Whether pregnancy is resulted or not	9 to 12 days after the transfer

External Links

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