NCT05811065

Brief Summary

A multi-center randomized clinical trial is proposed to study the effectiveness of the advanced decision support tool Opt-IVF 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
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 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

March 15, 2023

Completed
5 days until next milestone

Study Start

First participant enrolled

March 20, 2023

Completed
24 days until next milestone

First Posted

Study publicly available on registry

April 13, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 25, 2023

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2023

Completed
Last Updated

December 7, 2023

Status Verified

December 1, 2023

Enrollment Period

4 months

First QC Date

March 15, 2023

Last Update Submit

December 5, 2023

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 M2 follicles

    Total Number of M2 follicles

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

  • Total Number of Embryos

    Total Number of Embryos fertilized

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

  • Number of high-quality blastocyte

    Total number of high-quality blastocyte

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

  • Total FSH+HMG Dosage for the complete cycle

    Total FSH+HMG Dosage for the complete cycle

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

  • Pregnancy rate

    pregnancy rate

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

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

This arm will use doctor specified treatment

Device: traditional drug treament

Interventions

OPTIVF dosageDEVICE

Opt-IVF dosage

OPTIVF predicted drug dosage
traditional drug treamentDEVICE

Traditional drug treatment

Traditional drug treatment

Eligibility Criteria

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

You may qualify if:

  • All-female patients undergoing IVF with own oocyte

You may not qualify if:

  • PCOD
  • Endometriosis
  • Uncontrolled Diabetes
  • Uncontrolled thyroid abnormalities Uncontrolled hyperprolactinemia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Indira IVF

Mumbai, Maharashtra, India

Location

Related Publications (4)

  • 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

  • Diwekar U, Gupta S, Gahlan A, Hota S, Murdia K, Murdia N, Chandra V, Bhoi N, Joag S. A new decision-support tool in a multi-center randomized trial for personalized, optimized, and simplified fertility treatment in non-PCOS patients. Reprod Fertil. 2024 Sep 16;5(3):e240013. doi: 10.1530/RAF-24-0013. Print 2024 Jul 1.

    PMID: 39159260DERIVED

Study Officials

  • Urmila Diwekar, Ph.D.

    Stochastic Research Technologies LLC/University of Illinois at Chicago

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This is a multi-centric randomized clinical trial study with two arms (one arm for OPTIVF and one arm for the conventional approach) . In our 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

March 15, 2023

First Posted

April 13, 2023

Study Start

March 20, 2023

Primary Completion

July 25, 2023

Study Completion

July 31, 2023

Last Updated

December 7, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will share

We will provide deidentified data.

Shared Documents
STUDY PROTOCOL, CSR
Time Frame
After publication of results
Access Criteria
by writing to PI

Locations

IN(1)