Recruiting
Phase 1
Phase 2

Opt-IVF

Sponsor:

Urmila DIwekar

Code:

NCT07148999

Conditions

Infertility (IVF Patients)

Eligibility Criteria

Sex: Female

Age: 20 - 50

Healthy Volunteers: Accepted

Interventions

Opt-IVF

Control

Study Details

Brief summary:

A clinical trial will determine the effectiveness of using the Opt-IVF decision support tool for each patient's personalized and optimal drug dosage profile in the United States.

Conditions

Infertility (IVF Patients)

Study ID

NCT07148999

Start date

Sep 23, 2025

Status verified date

Sep, 2025

Completion date

Feb 15, 2026

Anticipated

Primary completion date

Feb 15, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 20 - 50

Healthy Volunteers: Accepted

Inclusion Criteria:

  • infertile women

Exclusion Criteria:

All female patients who will not undergo IVF or whose cycles will be converted to IUI. Male patients will not be enrolled in this study. No donor cycles.

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Control

This arm will get dosage prescribed by the doctor

experimental: Opt-IVF

This arm patients will get dosage provided by Opt-IVF

Interventions

Opt-IVF

Opt-IVF provides optimized dosage profile for each patient

Control

Physicians will decide the dosage for each day for patients

Primary outcome measure

  • Total Gonadotropin Dosage [ Time Frame: Two weeks after the start of the cycle ]
  • Total Oocytes Retrieved [ Time Frame: Two weeks after the start of the stimulation cycle ]
  • M2 Oocytes [ Time Frame: Two weeks after the start of the stimulation cycle ]
  • Total Embryos Formed [ Time Frame: Two weeks after the start of stimulation cycle ]
  • Grade A embryos/Blastocytes [ Time Frame: Three weeks after the start of stimulation cycle ]

Central Contacts and Locations

Central contacts

Urmila Diwekar, Ph.D.

6308863047urmila@vri-custom.org

Sanjay Joag, M.D., Ph.D.

6305014451sanjay@opt-ivf.com

Locations

Positivf Fertility

Recruiting

Houston, Texas, United States, 77054

Contacts

Paul Magarelli, MD, Ph.D.

719-331-6392pcmagarelli@gmail.com

Positivf Fertility

Recruiting

San Antonio, Texas, United States, 78249

Contacts

Francisco Arrendendo, MD, MPh

210-404-2229paco@positivf.com

More Information

Sponsor

Urmila DIwekar

Last update posted

Sep 29, 2025

Last verified

Sep, 2025

Keywords

  • Opt-IVF

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Urmila DIwekar on 2025-09-29.