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Completed

NCT Number: NCT05377879

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

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.

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Key information

Conditions

IVF

Age range

20 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Akansha Hospital and Research Institute

Anand, Gujarat, 388001, India

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women undergoing infertility treatment

Exclusion criteria

  • No male participants

Treatment and study plan

OPT-IVF dosage

Device

Dosage predicted for each patient by the decision support tool OPTIVF

Primary outcomes

  1. Number of follicles retrieved

    Time frame: At the end of cycle 1 (each cycle ranges from 10 to 12 days)

    follicles retrieved

  2. Number of M2s

    Time frame: At the end of cycle 1(each cycle ranges from 10 to 12 days)

    Number of M2s retrieved

  3. No. of Very Good Embryos

    Time frame: At the end of cycle 1 (each cycle ranges from 10 to 12 days)

    Grade A Embryos

Secondary outcomes

  1. Pregnancy

    Time frame: 9 to 12 days after the transfer

    Whether pregnancy is resulted or not

Sponsors and collaborators

Lead sponsor

Stochastic Research Technologies LLC

Industry

Collaborators

  • Akansha Hospital and Research Institute, India

Registry information

Official study title

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

Acronym: OPT-IVF

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
May 17, 2022
Registry last updated
Jul 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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