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

75 Participants Needed

Trial Summary

What is the purpose of this trial?

This study aims to assess the clinical significance of cleavage stage (Day 3) assisted hatching compared to assisted hatching at the blastocyst stage (Day 5,6,7) of embryo development at the time of trophectoderm (TE) biopsy for patients undergoing in vitro fertilization (IVF) and preimplantation genetic testing for aneuploidy (PGT-A) for treatment of their infertility.

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 data supports the effectiveness of the treatment Laser Assisted Hatching for Infertility?

Research suggests that laser-assisted hatching can improve pregnancy and implantation rates, especially in women with a poor prognosis for pregnancy, such as those of advanced age or with previous IVF failures. It is considered one of the best techniques for assisted hatching, potentially leading to better outcomes in assisted reproductive technologies. ^{1 2 3 4 5}

Is laser-assisted hatching safe for humans?

Research shows that laser-assisted hatching is generally safe for humans. Studies found no increase in major congenital malformations or chromosomal issues in children born after the procedure, and it did not increase the risk of obstetrical or neonatal complications. ^{6 7 8 9 10}

How does the treatment Laser Assisted Hatching differ from other treatments for infertility?

Laser Assisted Hatching (LAH) is unique because it uses a precise laser to thin or create a small opening in the outer shell of an embryo, which can help improve the chances of implantation and pregnancy, especially in older women or those with a poor prognosis. This method is considered more effective than traditional techniques like using a micropipette, as it can increase pregnancy and implantation rates in assisted reproduction. ^{1 2 9 11 12}

Research Team

Jason Fransiak, MD

Principal Investigator

Reproductive Medicine Associates of New Jersey

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. Turkey pubmed.ncbi.nlm.nih.gov

Comparison of the impact of laser-assisted hatching on fresh cleavage and blastocyst embryo transfer and association with pregnancy outcomes. [2022]

2. France pubmed.ncbi.nlm.nih.gov

[Assisted hatching: procedure and effectiveness]. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Effect of laser zona pellucida opening on clinical outcome of assisted reproduction technology in patients with advanced female age, recurrent implantation failure, or frozen-thawed embryos. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

A retroprospective study comparing three different assisted hatching techniques. [2009]

5. United States pubmed.ncbi.nlm.nih.gov

Laser versus mechanical assisted hatching: a prospective study of clinical outcomes. [2019]

6. Netherlands pubmed.ncbi.nlm.nih.gov

No adverse effects were identified on the perinatal outcomes after laser-assisted hatching treatment. [2022]

7. Iran pubmed.ncbi.nlm.nih.gov

Laser assisted zona hatching does not improve live birth rate in patients undergoing their first ICSI cycles. [2021]

8. Ireland pubmed.ncbi.nlm.nih.gov

A follow-up study of children born after diode laser assisted hatching. [2022]

9. Croatia pubmed.ncbi.nlm.nih.gov

Laser-assisted hatching in assisted reproduction. [2007]

10. England pubmed.ncbi.nlm.nih.gov

Obstetric, neonatal and child development outcomes following assisted hatching treatment: a retrospective cohort study. [2021]

11. Korea (South) pubmed.ncbi.nlm.nih.gov

The effect of various assisted hatching techniques on the mouse early embryo development. [2022]

12. Singapore pubmed.ncbi.nlm.nih.gov

A study comparing three different laser-assisted hatching techniques. [2020]