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IVM Protocol

In Vitro Maturation for Polycystic Ovary Syndrome (IVMprt Trial)

N/A

Recruiting

Led By Bruce I Rose, MD, PhD

Research Sponsored by Bruce Rose, MD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to one year after transfer of last patient enrolled

Awards & highlights

IVMprt Trial Summary

This trial found that a specific IVM protocol improved pregnancy results compared to other published studies. The protocol includes the use of the Steiner-Tan needle, oral medications, and low doses of FSH, and delayed embryo transfer.

Who is the study for?

This trial is for individuals with Polycystic Ovary Syndrome (PCOS) who have a specific pattern in their ovaries and more than 25 antral follicles. They must also have an AMH level over 3.5. It's not suitable for those with a BMI over 35, body shape that complicates egg retrieval, or medical conditions that make pregnancy or IVF risky.Check my eligibility

What is being tested?

The study tests a new protocol to improve pregnancy rates using in vitro maturation (IVM) of oocytes in PCOS patients. This includes using the Steiner-Tan needle during retrieval, low-dose FSH and oral meds for priming, and delayed embryo transfer after warming cryo-preserved embryos.See study design

What are the potential side effects?

While the description doesn't specify side effects, IVM procedures can generally include abdominal pain, bloating, mood swings from hormonal treatment, and rare risks like ovarian hyperstimulation syndrome.

IVMprt Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to one year after transfer of last patient enrolled

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to one year after transfer of last patient enrolled

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to one year after transfer of last patient enrolled for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percentage of treated patients having a clinical pregnancy

Percentage of treated patients having an ongoing pregnancy

Secondary outcome measures

Percentage of fertilized oocytes which became blastocysts per patient

Percentage of fertilized oocytes which divided

Percentage of patients who have a biochemical pregnancy after therir first transfer

+2 more

Other outcome measures

Number of clinical pregnancies from subsequent transfers

Number of ongoing pregnancies from subsequent transfers

IVMprt Trial Design

1Treatment groups

Experimental Treatment

Group I: AllExperimental Treatment1 Intervention

Patients requiring IVF treatment with PCOS or a PCO pattern in their ovaries who wish to undertake IVM (as a variant of their IVF procedure)

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Bruce Rose, MDLead Sponsor

Bruce I Rose, MD, PhDPrincipal InvestigatorBrown Fertility

Media Library

IVM With Low Cost Priming, Enhanced Oocyte Recovery, and Delayed Transfer (IVM Protocol) Clinical Trial Eligibility Overview. Trial Name: NCT04149496 — N/A

Polycystic Ovary Syndrome Research Study Groups: All

Polycystic Ovary Syndrome Clinical Trial 2023: IVM With Low Cost Priming, Enhanced Oocyte Recovery, and Delayed Transfer Highlights & Side Effects. Trial Name: NCT04149496 — N/A

IVM With Low Cost Priming, Enhanced Oocyte Recovery, and Delayed Transfer (IVM Protocol) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04149496 — N/A

Polycystic Ovary Syndrome Patient Testimony for trial: Trial Name: NCT04149496 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who meets the eligibility criteria for this research project?

"Eligibility into this medical trial necessitates having sclerocystic ovaries and being between 18 and 38 years old. Approximately 300 individuals are sought to participate in the study."

Answered by AI

How many participants are included in this research endeavor?

"Affirmative. Information available on clinicaltrials.gov indicates that this research trial, which was posted in May 2019 and last revised in October of the same year, is currently recruiting participants. Three hundred patients must be sourced from one medical centre for inclusion in this study."

Answered by AI

Are octogenarians being included in this medical experiment?

"Eligibility for this research project is restricted to individuals between the ages of 18-38."

Answered by AI

Is there an open enrollment process for this experiment?

"Confirming the details on clinicaltrials.gov, it appears that this research is still open to patient enrollment. The initial posting was made in May of 2019 and edited for the last time during October of the same year."

Answered by AI

What is the main goal of this trial?

"The primary objective of this trial, which will be monitored for roughly 12 weeks post-transfer is to gauge the proportion of treated patients who have ongoing pregnancies. Secondary outcomes encompass percentage of individuals with a biochemical pregnancy after their first transfer (measured as hCG level over 5), retrieved oocytes that mature within 48 hours, and fertilized oocytes that divide into two or more cells."

Answered by AI