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RecruitingNCT07856082Updated Oct 2, 2026

Opt-IVF for Personalized Medicine for Normal Responders

A Phase 1/2 interventional study of Opt-IVF and control in Ivf, sponsored by Urmila DIwekar. Recruiting at 1 site in United States. Open to female participants aged 20 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-10-02.

Sponsored by Urmila DIwekar · Phase 1/2, Interventional, and Treatment

Updated Oct 2, 2026Newly registeredGo to Updates ↓
Phase
Phase 1/2
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
20 Years to 50 Years
Sex
Female
01

Study summary

A clinical trial will determine the effectiveness of the Opt-IVF decision-support tool in generating personalized, optimal drug-dosage profiles for each patient in the United States.

Read the detailed description

This will be a two-arm randomized clinical trial involving more than 100 patients; one arm will undergo superovulation using dosages predicted by the decision-support tool, while the other will receive the current standard treatment. The research question is whether outcomes of patient dosage treatment using Opt-IVF are better or similar to the current practice. We will compare the outcomes of the two groups of patients 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, total number of M2s, Number of embryos, Number of Grade A embryos, and Number of Grade A blastocysts.

02

Conditions studied

  • Ivf

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Keywords

  • Infertility
  • IVF
  • Antagonist
  • PPOS
03

In context

Infertility

2,506 studies on the registry are indexed under Infertility; 407 are open to participants now.

This study's planned enrollment of 100 is below the median of 120 across 1,698 interventional studies indexed under Infertility.

Browse Infertility studies →

Lead sponsor

Urmila DIwekar is the lead sponsor of 2 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 50 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

Normal Responders

Exclusion criteria

Exclusion Criteria:

  • PCOS and Poor Responders
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    Opt-IVF

    Opt-IVF 1.0 arm will receive personalized total-gonadotropin optimization predicted dosage per day

    Device: Opt-IVF

  • Active comparator
    Control

    This standard-care arm will receive physician-directed dosing

    Other: control

Interventions

  • DeviceOpt-IVF

    Opt-IVF predicted dosage for IVF

  • Othercontrol

    Doctor prescribed dosage

06

What researchers measure

Primary outcomes

  1. Total Gonadotropin dosage

    Total Dosage

    Time frame: 11 days

Secondary outcomes

  1. M2 Oocytes

    M2 Oocytes

    Time frame: 13 days

  2. Total Embryos

    Number of Embryos

    Time frame: 15 days

  3. Grade A Blastocysts

    No. of Grade A blastocysts

    Time frame: 20 days

07

Study locations

1 of 1 sites recruiting
  • ABC IVF
    West Palm Beach, Florida 33407, United States
    Recruiting
08

References and documents

Publications

  • Diwekar U, Bhoi N, Gupta S, Sharma A, Hota S, Lunkad A, Arora S, Kumari S, Naik A, Batra T, Naik S, Jangid A, Kumar P, Kumar S, Joag S. A multicenter randomized clinical trial with a novel decision support tool to improve IVF success. Reproduction and Fertility. 2025 July; 6(3):-. doi: 10.1530/RAF-25-0004.

Individual participant data

Plan to share: Yes — by contacting the PI.

Supporting information: Study protocol, Sap, Icf, Csr

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 2, 2026
Show all 1 update
  1. Oct 2, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07856082
Lead sponsor
Urmila DIwekar
Responsible party
Urmila DIwekar (President, Stochastic Research Technologies LLC) — Sponsor-investigator
First posted
Oct 2, 2026
Start date
Oct 15, 2026 (estimated)
Primary completion
Mar 31, 2027 (estimated)
Completion
Apr 30, 2027 (estimated)
Last update
Oct 2, 2026

Study contacts

Urmila Diwekar, Ph.D.
Contact
urmila@opt-ivf.com
6308863047
Sanjay Joag, M.D., Ph.D.
Contact
sanjay@opt-iVF.com
6305014451
Dr. Paul Magarelli, M.D., Ph.D.
principal investigator · The American Baby Company

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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