Opt-IVF for Infertility

Recruiting at 1 trial location

Overseen By Sanjay Joag, M.D., Ph.D.

Age: 18 - 65

Sex: Female

Trial Phase: Phase 1 & 2

Sponsor: Urmila DIwekar

Disqualifiers: Not undergoing IVF, Male, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve infertility treatment by testing a new tool called Opt-IVF. The researchers seek to determine if this tool can better personalize and optimize drug dosages for women undergoing IVF (in vitro fertilization) in the United States. Participants will receive either the standard doctor-prescribed dosage or the dosage recommended by the Opt-IVF tool. Women diagnosed with infertility and planning to undergo IVF treatments are ideal candidates for this trial. As a Phase 1, Phase 2 trial, this research seeks to understand how the treatment works in people and measure its effectiveness in an initial group, offering participants a chance to contribute to groundbreaking advancements in IVF treatment.

Do I need to stop my current medications for the Opt-IVF trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to ask the trial coordinators for more details.

What prior data suggests that the Opt-IVF decision support tool is safe for use in determining drug dosages?

Research has shown that Opt-IVF, a tool for customizing drug doses in infertility treatments, has been tested in several studies. These studies evaluated the tool's effectiveness and found no major safety issues.

One study aimed to determine if Opt-IVF could lead to more pregnancies compared to usual methods. It showed better pregnancy results, with no reports of harm or side effects. Another study used Opt-IVF to guide drug doses for fertility treatments, and again, no serious safety concerns emerged.

Since the trial is in its early stages, it primarily focuses on assessing safety and tolerance. While no serious risks have been reported so far, more information is needed to fully understand its safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Opt-IVF is unique because it offers a potentially more tailored approach to infertility treatment compared to standard IVF procedures. Unlike traditional IVF, where medication dosages are often standardized, Opt-IVF customizes the dosage provided to patients, potentially improving treatment outcomes. Researchers are excited about this approach because it may enhance the success rates of IVF by better aligning treatment with individual patient needs. This personalization could lead to more efficient use of resources and shorten the time to achieve pregnancy.

What evidence suggests that the Opt-IVF decision support tool is effective for infertility?

Research has shown that Opt-IVF, which participants in this trial may receive, can enhance IVF treatment outcomes. Studies found that patients using Opt-IVF produced 20% more embryos overall and 50% more high-quality embryos compared to those not using it. Patients also required 30% less hormone medication, reducing the amount of medicine taken. Additionally, the tool increased pregnancy rates by tailoring drug doses to each individual. These findings suggest that Opt-IVF could be a promising tool for improving IVF success. ^{1 2 3 6 7}

Who Is on the Research Team?

Francesco Arredondo, MD, Ph.D.

Principal Investigator

Positivf Fertility

Paul Magarelli, M.D., Ph.D.

Principal Investigator

IVF Academy USA

Are You a Good Fit for This Trial?

This trial is for infertile women who are planning to undergo in vitro fertilization (IVF). It's not open to those who won't have IVF or whose treatment might switch to intrauterine insemination (IUI), men, or anyone using donor cycles.

Inclusion Criteria

I am a woman who cannot become pregnant.

Exclusion Criteria

I am not planning IVF, or my treatment will change to IUI.

I am a male.

I have not donated eggs or sperm.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Stimulation Cycle

Participants undergo superovulation using dosages predicted by the decision support tool or standard treatment

2-3 weeks

Multiple visits for monitoring and dosage adjustments

Follow-up

Participants are monitored for safety and effectiveness after the stimulation cycle

4 weeks

Follow-up visits to assess outcomes and collect data

Pregnancy Monitoring

Cycle pregnancy rate monitored until the first transfer

1 month

What Are the Treatments Tested in This Trial?

Interventions

• Opt-IVF

Trial Overview The study is testing the Opt-IVF tool, which helps personalize medication dosages for IVF. Participants will either use this new decision support tool (Opt-IVF) or follow standard care protocols (Control) to see if there's a difference in outcomes.

How Is the Trial Designed?

Group I: Opt-IVF Experimental Treatment 1 Intervention

This arm patients will get dosage provided by Opt-IVF

Group II: Control Active Control 1 Intervention

This arm will get dosage prescribed by the doctor

Who Is Running the Clinical Trial?

Urmila DIwekar

Lead Sponsor

IVF Academy of USA

Collaborator

Positivf Fertility

Collaborator

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11466266/

A new decision-support tool in a multi-center randomized ... This approach resulted in increased high-quality blastocysts and higher pregnancy rates compared to control patients. Opt-IVF shows promise as a valuable tool ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06179420

The Effectiveness of Advanced Decision Support Tool ... The data is used in the Opt-IVF decision support tool to suggest Gonadotropin dosage for D5 and beyond and to recommend the antagonist start day and trigger ...

3. opt-ivf.com opt-ivf.com/clinicalResults.html

Clinical Trial Results Certain patient characteristics predict lower success rates during IVF. These include older patients (age>35 years). While our clinical trials conducted were ...

4. fertstert.org fertstert.org/article/S0015-0282(25)00315-2/fulltext

Optimizing Clinical Pregnancy and Live Birth Rates with ... Embryo Count: The Opt-IVF group had 20% more total embryos (p < 0.001) and 50% more high-quality embryos (p< 0.0001) than the control group.

5. opt-ivf.com opt-ivf.com/

Opt-IVF™ "The results were impressive across all key metrics: a 30% reduction in the overall hormone dosage, a 50-75% decrease in testing, and a greater number of Grade ...

6. opt-ivf.com opt-ivf.com/paper.pdf

A Non-Randomized Clinical Trial of a Decision Support ... This trial was designed as a non-inferiority trial to test the proposition that using Opt-IVF, a clinical decision support tool, to guide superovulation would ...

7. scienceopen.com scienceopen.com/document_file/d1303612-2bc1-4359-a95d-f244d7aca1d0/PubMedCentral/d1303612-2bc1-4359-a95d-f244d7aca1d0.pdf

A multicenter randomized clinical trial with a novel decision ... The results demonstrated that the Opt-IVF group had significantly better outcomes across all metrics, including clinical pregnancy rates. In ...