Laser Assisted Hatching for Infertility

(IMPACT Trial)

Overseen By Kevin Lambrese, PhD

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Reproductive Medicine Associates of New Jersey

Disqualifiers: Failed IVF, Donor oocyte, Gestational carriers, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 1 week

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the optimal timing for a laser technique called assisted hatching to aid embryo development during in vitro fertilization (IVF). Researchers aim to determine whether performing this procedure on Day 3 or on Days 5, 6, or 7 is more effective for women undergoing genetic testing of embryos to treat infertility. The laser assists the embryo in breaking out of its shell, potentially increasing the chances of a successful pregnancy. This trial may suit women under 42 who plan an IVF cycle and wish to transfer a top-quality embryo. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance IVF success rates.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that laser assisted hatching is safe for infertility treatment?

Research has shown that laser-assisted hatching (LAH) is safe for babies' development. Studies have found no link between LAH and developmental delays or health problems in children. Although LAH is frequently used in fertility treatments, experts continue to debate its effectiveness in increasing live birth rates. However, it has helped embryos attach to the womb, potentially improving implantation rates. Overall, from a safety standpoint, LAH appears well-tolerated and does not harm the baby. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about laser assisted hatching for infertility because it offers a potentially enhanced method for improving embryo implantation success during in vitro fertilization (IVF). Unlike the standard practice of assisted hatching at the cleavage stage (day 3 embryos), this technique focuses on hatching the embryo at the blastocyst stage (days 5, 6, or 7), which may align better with natural embryo development. This laser technique precisely thins or creates an opening in the zona pellucida, the outer shell of the embryo, potentially increasing the chances of successful implantation. By optimizing the timing and precision of this method, researchers hope to improve pregnancy rates for individuals undergoing IVF.

What evidence suggests that laser assisted hatching is effective for infertility?

This trial will compare the effectiveness of Laser Assisted Hatching (LAH) at different embryo stages. Research has shown that LAH can improve pregnancy outcomes in IVF treatments. Some studies have found that LAH increases the likelihood of embryos attaching to the womb and raises pregnancy rates. For example, one study found that LAH improved the chances of embryo attachment by about 26% compared to not using it. However, other research suggests that LAH might not significantly impact the number of live births. Overall, while LAH appears to aid embryo attachment, its effect on actual birth rates remains under debate. ^{1 2 3 6 7}

Who Is on the Research Team?

Jason Fransiak, MD

Principal Investigator

Reproductive Medicine Associates of New Jersey

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

<4 2PNs prior to randomization

Patients undergoing an IVF cycle with plan for subsequent FET of a single euploid embryo

My female partner is under 42 years old.

Exclusion Criteria

All patients who do not voluntarily give their written consent for participation

Patients with a prior failed IVF cycle - defined as no blastocysts

Patients with a history of more than one failed euploid embryo transfer

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo assisted hatching procedures at either the cleavage stage (Day 3) or blastocyst stage (Day 5, 6, 7) as part of IVF and PGT-A

1 week

Follow-up

Participants are monitored for outcomes such as blastulation rate, embryo morphologic grade, and aneuploidy rate

2 weeks

Long-term Follow-up

Participants are monitored for live birth rate, positive pregnancy rate, pregnancy loss rate, and sustained implantation rate

7 months

What Are the Treatments Tested in This Trial?

Interventions

• Laser Assisted Hatching

Trial Overview 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.

How Is the Trial Designed?

Group I: Cleavage Stage Assisted Hatching (AH) Experimental Treatment 1 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 Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Reproductive Medicine Associates of New Jersey

Lead Sponsor

Trials

56

Recruited

38,200+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9935798/

Laser-assisted hatching improves pregnancy outcomes in ... Although ART has achieved a 30–50% average pregnancy rate [1], the embryo implantation rate (IR) remains low, at about 20–30% [2]. Implantation, ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12098289/

insight of systematic review and meta-analysis into laser ... LAH significantly improved implantation rates (OR: 1.26, 95% CI: 1.05–1.51). Clinical pregnancy rates increased in patients who had fresh ...

3. bmcpregnancychildbirth.biomedcentral.com bmcpregnancychildbirth.biomedcentral.com/articles/10.1186/s12884-024-06380-8

Two laser-assisted hatching methods of embryos in ART Overall, the LAH method didn't significantly affect clinical pregnancy outcomes. However, D-LAH showed a higher rate of singleton pregnancies ...

4. asrm.org asrm.org/practice-guidance/practice-committee-documents/the-role-of-assisted-hatching-in-in-vitro-fertilization-a-guideline-2022/

Role of assisted hatching in in vitro fertilization: a guideline ... There is moderate evidence that assisted hatching does not significantly improve live birth rates in fresh assisted reproductive technology cycles.

5. sciencedirect.com sciencedirect.com/science/article/pii/S1642431X2400069X

Exploring the benefit of different methods to perform ... Their results showed both implantation and clinical pregnancy rates to be significantly higher in the T-LAH group compared to the D-LAH group (32.73 % versus ...

6. obgyn.onlinelibrary.wiley.com obgyn.onlinelibrary.wiley.com/doi/10.1111/1471-0528.18047

Impact of Laser‐Assisted Hatching on Cognitive and ... The findings of the study indicate that LAH did not confer an increased risk of developmental delay, metabolic abnormalities or intelligence ...

7. fertstert.org fertstert.org/article/S0015-0282(24)00091-8/fulltext

The effect of laser-assisted hatching on vitrified/warmed ... The relative risk of live birth in patients with vitrified-warmed blastocysts treated with AH was 1.02 (95% confidence interval, 0.86–1.19; P=.