NCT05981898

Brief Summary

A multi-center randomized clinical trial is proposed to study the effectiveness of the advanced decision support tool Opt-IVF for ALL PROTOCOLS in reducing medication, testing, and improving outcomes.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
550

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 31, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 8, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

September 15, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2024

Completed
Last Updated

July 17, 2024

Status Verified

September 1, 2023

Enrollment Period

6 months

First QC Date

July 31, 2023

Last Update Submit

July 16, 2024

Conditions

IVF

Keywords

IVFOpt-IVF

Outcome Measures

Primary Outcomes (6)

  • Number of Follicles retrieved

    Mature follicles retrieved

    at the end of cycle (each cycle is 17 days)

  • Number of Mii Follicles

    Number of Mii Follicles

    at the end of cycle (each cycle is 17 days)

  • Total number of Embryos

    Total number of Embryos

    at the end of cycle (each cycle is 17 days)

  • Number of Grade A embryos

    Number of Grade A embryos

    at the end of cycle (each cycle is 17 days)

  • Total FSH+HMG Dosage in IUI for the complete cycle

    Total FSH+HMG Dosage in IUI for the complete cycle

    at the end of cycle (each cycle is 17 days)

  • Clinical Pregnancy Rate

    Clinical Pregnancy Rate

    One month after implantation

Study Arms (2)

OPTIVF predicted drug dosage

EXPERIMENTAL

This arm will use dosage, trigger predicted by Opt-IVF

Device: OPTIVF dosage

Traditional drug treatment

ACTIVE COMPARATOR

Traditional drug treatment

Device: traditional Dosage

Interventions

OPTIVF dosageDEVICE

Dosage predicted by Opt-IVf

OPTIVF predicted drug dosage
traditional DosageDEVICE

Dosage used traditionally by doctors

Traditional drug treatment

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsIf is a fertility treatment for women
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • All-female patients undergoing IVF with own oocyte

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Indira IVF

Udaipur, Rajsthan, India

Location

Related Publications (3)

  • Diwekar et al., 2022, A Non-Randomized Clinical Trial of a Decision Support Tool to Optimize Superovulation Cycles in Individual Patients, J Fertil In vitro IVF Worldw Reprod Med Genet Stem Cell Biol, Vol.10 Iss.3 No:1000268 Link to the paper: https://www.longdom.org/open-access/a-nonrandomized-clinical-trial-of-a-decision-support-tool-to-optimize-superovulation-cycles-in-individual-patients-93998.html

    BACKGROUND

  • 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: 31809718RESULT

  • 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: 23193444RESULT

Related Links

Study Officials

  • Urmila Diwekar

    Stochastic Research Technologies LLC/University of Illinois at Chicago

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
The investigator and outcomes assessor Dr. Urmila Diwekar will only know the de-identified patient details in each arm after the treatment.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This is a multi-centered randomized clinical trial study with two arms (one arm for OPTIVF and one arm for the conventional approach) In this study, the tool will be using the patient's age and day three serum AMH and FSH levels to decide the starting dose for the patient's cycle. Tool 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.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 31, 2023

First Posted

August 8, 2023

Study Start

September 15, 2023

Primary Completion

March 15, 2024

Study Completion

April 15, 2024

Last Updated

July 17, 2024

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will share

We will provide deidentified data.

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
After publication of results
Access Criteria
contact PI

Locations

IN(1)