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?

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.

Who Is on the Research Team?

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

Principal Investigator

IVF Academy USA

Francesco Arredondo, MD, Ph.D.

Principal Investigator

Positivf Fertility

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