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Procedure

Laser Assisted Hatching for Infertility (IMPACT Trial)

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
Must not have
Male partner with <100,000 total motile spermatozoa per ejaculate (donor sperm is acceptable)
Use of surgical procedures to obtain sperm
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 40 weeks gestation or 7 months post discharge
Awards & highlights
No Placebo-Only Group

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.
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.
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My fertility tests show normal ovarian function and my BMI is under 38.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My partner has low sperm count or we are using donor sperm.
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I have undergone surgery to collect sperm.
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I have a fallopian tube condition and no surgery planned before embryo transfer.
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My uterus lining is too thin or I have persistent fluid in my uterus.
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I need detailed genetic testing for my embryo beyond standard screening.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Blastulation Rate
Secondary study objectives
Aneuploidy rate
Embryo morphologic grade
Live birth rate
+4 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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.

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Who is running the clinical trial?

Reproductive Medicine Associates of New JerseyLead Sponsor
53 Previous Clinical Trials
37,859 Total Patients Enrolled
31 Trials studying Infertility
19,318 Patients Enrolled for Infertility
Jason Fransiak, MDPrincipal InvestigatorReproductive Medicine Associates of New Jersey
~31 spots leftby May 2025
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