IVFOPT-IVFNCT05377879
An Advanced Decision Support Tool for Personalized Medicine for IVF Using Modeling and Optimization
A study testing OPT-IVF dosage in people with IVF, run by Stochastic Research Technologies LLC at 1 site in India.
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… Read more about this study
- Who is it for?
- Ages 20 to 50 years, women only
- Conditions the study is for
- IVF
- What is being tested?
- OPT-IVF dosage
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteIndia
- Study dates
- 10 May 2022to 1 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women undergoing infertility treatment
Who cannot join
- No male participants
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- IVF
- Being tested
- OPT-IVF dosage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OPT-IVF dosageDevice
Dosage predicted for each patient by the decision support tool OPTIVF
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of follicles retrieved
follicles retrieved
Measured: At the end of cycle 1 (each cycle ranges from 10 to 12 days)
Number of M2s
Number of M2s retrieved
Measured: At the end of cycle 1(each cycle ranges from 10 to 12 days)
No. of Very Good Embryos
Grade A Embryos
Measured: At the end of cycle 1 (each cycle ranges from 10 to 12 days)
Secondary outcomes (1)
Pregnancy
Whether pregnancy is resulted or not
Measured: 9 to 12 days after the transfer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2022
- Study start10 May 2022
- Primary completion30 Jun 2022
- Study completion1 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for IVFStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- OPT-IVF is a decision support tool which personalizes and optimizes dosage for each patient for each cycle.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stochastic Research Technologies LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Akansha Hospital and Research Institute, India
- Responsible party
- Sponsor
- Investigators
- Urmila Diwekar, Ph.D., Principal investigator, Stochastic Research Technologies/University of Illinois at Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05377879
- Sponsor's protocol ID
- opivf-protocol-22-1
- Acronym
- OPT-IVF
- Status last verified
- Jul 2022
- First submitted
- 4 May 2022
- Last updated
- 21 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Please contact urmila@vri-custom.org for IPD.
Publications
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.
PubMed 31809718Yenkie 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.
PubMed 23193444Yenkie 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.
PubMed 25484007
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05377879
- Acronym / sponsor ID
- OPT-IVF / opivf-protocol-22-1
- Conditions
- IVF
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Stochastic Research Technologies LLCIndustry (pharma, biotech, devices)
- Collaborators
- Akansha Hospital and Research Institute, India
- Study start
- 10 May 2022 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 1 Jul 2022 (actual)
- First posted
- 17 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- OPT-IVF is a decision support tool which personalizes and optimizes dosage for each patient for each cycle.
| Arm | Type | Receives |
|---|---|---|
| OPTIVF predicted drug dosage | Experimental | Device: OPT-IVF dosageIn 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. |
| 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. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Women undergoing infertility treatment
Key exclusion criteria (1 listed)
- No male participants
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OPT-IVF dosageDosage predicted for each patient by the decision support tool OPTIVF | Device | OPTIVF predicted drug dosage |
Primary outcome
Number of follicles retrieved
Time frame: At the end of cycle 1 (each cycle ranges from 10 to 12 days)
follicles retrieved
Number of M2s
Time frame: At the end of cycle 1(each cycle ranges from 10 to 12 days)
Number of M2s retrieved
No. of Very Good Embryos
Time frame: At the end of cycle 1 (each cycle ranges from 10 to 12 days)
Grade A Embryos
1 secondary outcome
Pregnancy
Time frame: 9 to 12 days after the transfer
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2022.
- Background: PubMed 31809718Nisal 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.
- Background: PubMed 23193444Yenkie 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.
- Background: PubMed 25484007Yenkie 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.
- description is available at http://www.stochastic-research.com/InVitroFertilization.htmlLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Please contact urmila@vri-custom.org for IPD.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Urmila Diwekar, Ph.D. principal investigator
Stochastic Research Technologies/University of Illinois at Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OPT-IVF dosage in people with IVF, run by Stochastic Research Technologies LLC at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of follicles retrieved (time frame: At the end of cycle 1 (each cycle ranges from 10 to 12 days)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05377879, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2022.