Opt-IVF for In Vitro Fertilization

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Overseen BySanjay Joag, M.D., Ph.D.
Age: 18 - 65
Sex: Female
Trial Phase: Phase 1 & 2
Sponsor: Urmila DIwekar
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new tool called Opt-IVF, designed to help doctors select optimal drug dosages for individuals undergoing in vitro fertilization (IVF). The goal is to determine if this personalized approach can enhance IVF success rates compared to standard methods. Participants will either use the Opt-IVF tool or follow standard care with doctor-selected dosages. The trial seeks individuals with normal responses to fertility treatments, excluding those with conditions like polycystic ovary syndrome (PCOS) or a history of poor IVF response. As a Phase 1, Phase 2 trial, this research aims to understand how the treatment works in people and measure its effectiveness in an initial, smaller group.

What prior data suggests that the Opt-IVF decision-support tool is safe for generating personalized drug-dosage profiles?

Research has shown that the Opt-IVF tool has been used in other studies to adjust medication doses for individuals undergoing in vitro fertilization (IVF). This tool assists doctors in determining the appropriate medication amount for each person, aiming to improve success rates and reduce the need for frequent tests. Studies indicate that using Opt-IVF led to a 30% reduction in the overall hormone dose, meaning patients required less medication. This reduction can lower the risk of side effects and ease the process on the body.

Although specific safety data isn't mentioned, the fact that Opt-IVF has been studied in clinical trials suggests it is reasonably safe. In early-phase trials like this one, researchers focus on ensuring the treatment's safety for participants. If serious safety issues existed, it likely wouldn’t have reached this stage.

Overall, using Opt-IVF may help make IVF treatment more personalized and potentially safer by reducing medication use.12345

Why are researchers excited about this trial?

Researchers are excited about Opt-IVF because it offers a personalized approach to in vitro fertilization (IVF), tailoring the total-gonadotropin dosage to each individual's needs. Unlike standard IVF protocols, which typically rely on a physician's judgment for dosing, Opt-IVF uses predictive algorithms to optimize hormone levels, potentially increasing the chances of successful pregnancy. This method not only aims to improve outcomes but also to reduce the risks associated with over or under-stimulation, making the process safer for patients.

What evidence suggests that the Opt-IVF decision-support tool is effective for optimizing drug dosages in IVF?

Research has shown that the Opt-IVF tool, which participants in this trial may receive, yields promising results in improving IVF outcomes. Early findings suggest that women using Opt-IVF required much lower doses of medication and produced 20% more embryos, with a 50% increase in high-quality embryos. This indicates that the tool could enhance the chances of successful pregnancies, particularly for those who haven't responded well to traditional methods. These improvements underscore Opt-IVF's potential to customize treatments more effectively, increasing the likelihood of a successful pregnancy.678910

Who Is on the Research Team?

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

Principal Investigator

The American Baby Company

Are You a Good Fit for This Trial?

This trial is for people in the United States who are undergoing IVF treatment and are considered 'normal responders'—meaning they typically respond as expected to fertility medications. People with Long QT syndrome or other major health issues may not be eligible.

Inclusion Criteria

Normal Responders

Exclusion Criteria

I have been diagnosed with polycystic ovary syndrome (PCOS).
Poor Responders

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo superovulation using either personalized dosages predicted by the Opt-IVF tool or standard treatment dosages

3 weeks
Multiple visits for monitoring and dosage adjustments

Follow-up

Participants are monitored for safety and effectiveness after treatment, including the assessment of mature follicles, embryos, and blastocysts

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Opt-IVF

Trial Overview

The study compares a new tool called Opt-IVF, which helps doctors choose personalized medication doses during IVF, against standard care without this tool. Participants are randomly assigned to either group.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Opt-IVFExperimental Treatment1 Intervention
Group II: ControlActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Urmila DIwekar

Lead Sponsor

Citations

Making evidence-based decisions in reproductive medicine

When deciding whether to use a medical intervention, evidence regarding not only effectiveness but also safety and costs must be weighed.

IVF Success Stories: Defying the Statistics

Younger women with a good egg count and a healthy weight can achieve cumulative live-birth rates above 90 percent over several cycles, while ...

Three simple metrics to define in vitro fertilization success ...

Three simple metrics provide a transparent and highly accurate summary of ART outcomes. The first metric is the probability of having no ...

IVF Success Rates - fertility treatments

We have been able to maintain superior pregnancy rates despite transferring fewer than the average national number of embryos

IVF success rates higher at clinics that provide more ...

Success rates for in vitro fertilization are higher at clinics that voluntarily share more information than required by government regulators, ...

A multicenter randomized clinical trial with a novel decision ...

The results of the trial show that Opt-IVF tailors the dosage to the individual, reduces the need for testing, and improves outcomes for ...

Optimizing Clinical Pregnancy and Live Birth Rates with ...

Clinical Pregnancy Rates: Including cancelled cycles, the clinical pregnancy rate increased from 35% in the control group to 45% in the Opt-IVF group. o.

Clinical Results

Using Opt-IVF to guide gonadotropin doses in expected poor responders yields superior outcomes Certain patient characteristics predict lower success rates ...

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 ...

IVF Stimulation - personalized, optimized, and simplified using ...

The clinical trial demonstrated that utilizing the clinical decision support tool, Opt-IVF, to guide hormone dosing during superovulation ...