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Blastocyst Stage Assisted Hatching (AH) for Infertility (IMPACT Trial)

Q: Which individuals are eligible to take part in this research investigation?

Individuals aged between 18 and 42 years old with a diagnosis of <a href="https://www.withpower.com/clinical-trials/infertility">infertility</a> are eligible to participate in this research. The study aims to recruit 75 participants in total.

Q: Are there any available slots for patients to participate in this clinical trial?

Based on the information available on clinicaltrials.gov, recruitment for this particular trial is currently closed. The initial posting date was 5/1/2024, with the most recent update made on 4/17/2024. While this specific study isn't seeking participants at present, it's worth noting that there are presently 257 other trials actively accepting enrollees.

Q: Is the research study open to individuals below 18 years of age?

Individuals aged between 18 and 42 are eligible to enroll in this research study. There are a total of 12 investigations tailored for participants under 18 years old, and an additional 37 studies targeting individuals over the age of 65.

N/A

Waitlist Available

Led By Jason Fransiak, MD

Research Sponsored by Reproductive Medicine Associates of New Jersey

Eligibility Criteria Checklist

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

Must have

Normal ovarian reserve: AMH ≥ 1.2 ng/mL, AFC ≥ 8, FSH ≤ 12IU/L, BMI <38

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 40 weeks gestation or 7 months post discharge

Awards & highlights

IMPACT Trial Summary

This trial aims to compare the effectiveness of assisted hatching on Day 3 embryos to that on Day 5, 6, or 7 embryos during in vitro fertilization (IVF) for

Who is the study for?

This trial is for individuals undergoing IVF with PGT-A due to infertility. It's comparing the timing of a technique called assisted hatching, either on Day 3 at cleavage stage or later on Days 5-7 at blastocyst stage before TE biopsy.Check my eligibility

What is being tested?

The study tests whether laser-assisted hatching should be done earlier (Day 3) or later (Days 5-7) in embryo development to improve IVF success rates. Participants will have one of these two procedures randomly.See study design

What are the potential side effects?

Laser-assisted hatching may cause potential damage to embryos leading to reduced implantation rates, and there could be risks associated with multiple pregnancies if more than one embryo implants.

IMPACT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My fertility tests show normal ovarian function and my BMI is under 38.

IMPACT Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 40 weeks gestation or 7 months post discharge

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 40 weeks gestation or 7 months post discharge

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 40 weeks gestation or 7 months post discharge for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Blastulation Rate

Secondary outcome measures

Aneuploidy rate

Embryo morphologic grade

Live birth rate

+4 more

IMPACT Trial Design

2Treatment groups

Experimental Treatment

Group I: Cleavage Stage Assisted Hatching (AH)Experimental Treatment1 Intervention

Current standard of care. Day 3 or cleavage stage embryos will have the zona pellucida hatched with a laser.

Group II: Blastocyst Stage Assisted Hatching (AH)Experimental Treatment1 Intervention

Blastocyst stage embryos on day 5,6 or 7 will have the zona pellucida hatched with a laser.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Reproductive Medicine Associates of New JerseyLead Sponsor

52 Previous Clinical Trials

37,759 Total Patients Enrolled

30 Trials studying Infertility

19,218 Patients Enrolled for Infertility

Jason Fransiak, MDPrincipal InvestigatorReproductive Medicine Associates of New Jersey

Frequently Asked Questions

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

Which individuals are eligible to take part in this research investigation?

"Individuals aged between 18 and 42 years old with a diagnosis of infertility are eligible to participate in this research. The study aims to recruit 75 participants in total."

Answered by AI

Are there any available slots for patients to participate in this clinical trial?

"Based on the information available on clinicaltrials.gov, recruitment for this particular trial is currently closed. The initial posting date was 5/1/2024, with the most recent update made on 4/17/2024. While this specific study isn't seeking participants at present, it's worth noting that there are presently 257 other trials actively accepting enrollees."

Answered by AI

Is the research study open to individuals below 18 years of age?

"Individuals aged between 18 and 42 are eligible to enroll in this research study. There are a total of 12 investigations tailored for participants under 18 years old, and an additional 37 studies targeting individuals over the age of 65."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Investigating Micro-Manipulation Procedures for Assisted Hatching Timing

2024. "Investigating Micro-Manipulation Procedures for Assisted Hatching Timing". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06377917.

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