InfertilityIMPACTNCT06377917
Investigating Micro-Manipulation Procedures for Assisted Hatching Timing
A study testing Laser Assisted Hatching in people with Infertility, run by Reproductive Medicine Associates of New Jersey at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 42 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Laser Assisted Hatching
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 31 May 2026to 31 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 42 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Patients undergoing an IVF cycle with plan for subsequent FET of a single euploid embryo
- <4 2PNs prior to randomization
- Female partners age <42 years old at start of VOR cycle
- Normal ovarian reserve:
- AMH ≥ 1.2 ng/mL
- AFC ≥ 8
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- FSH ≤ 12IU/L
- BMI <38
- Patients who desire to transfer the best quality embryo for their embryo transfer.
Who cannot join
- 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
- Donor oocyte cycles
- Gestational Carriers
- Male partner with <100,000 total motile spermatozoa per ejaculate (donor sperm is acceptable)
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- Use of surgical procedures to obtain sperm
- Communicating hydrosalpinges without a plan for surgical correct prior to frozen embryo transfer
- Endometrial Insufficiency, as defined by a prior cycle with maximal endometrial thickness <6mm,), or persistent endometrial fluid
- Single gene disorders, chromosomal translocations, or any other disorders requiring a more detailed embryo genetic analysis than standard PGT-A
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Reproductive Medicine Associates of New Jersey
Marlton, New Jersey, 08053
Christine V Whitehead, MS, BSN, RN, 19736562841, clinicalresearchteam@ivirma.com
Caroline Zuckerman, BS, RN, 19736562841, clinicalresearchteam@ivirma.com
About this study
Official title: The IMPACT Trial: Investigating Micro-Manipulation Procedures for Assisted Hatching Timing
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.
Read the detailed description
The proposed study aims to perform a split cohort study where each patient's cohort of fertilized zygotes, (two pronuclei or 2PNs) is split into two groups and randomized, thus allowing each patient to serve as their own control and decreasing confounding variables. Half of the cohort will proceed with the current standard of day 3 or cleavage assisted hatching and the other half of the cohort will receive the sequential hatching and trophectoderm biopsy procedure at the blastocyst stage of embryo development.
- Conditions
- Infertility
- Being tested
- Laser Assisted Hatching
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser Assisted HatchingOther
Routine assisted hatching procedure will be performed on both groups at the different embryo developmental phases.
| Study group | Role | What they receive |
|---|---|---|
| Cleavage Stage Assisted Hatching (AH) | Other | Current standard of care. Day 3 or cleavage stage embryos will have the zona pellucida hatched with a laser. Receives: Other: Laser Assisted Hatching |
| Blastocyst Stage Assisted Hatching (AH) | Experimental | Blastocyst stage embryos on day 5,6 or 7 will have the zona pellucida hatched with a laser. Receives: Other: Laser Assisted Hatching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blastulation Rate
Blastulation rate per 2 pronuclei (PN) in each group
Measured: 1 week after vaginal oocyte retrieval (VOR)
Secondary outcomes (7)
Embryo morphologic grade
Gardner and Modified Gardner grading system will be used
Measured: 1 week post VOR
Timing of blastulation
proportion of blastocysts that blastulate on day 5,6 or 7
Measured: 1 week post VOR
Aneuploidy rate
Rates of whole chromosome positive and negative preimplantation genetic testing (PGT-A) results
Measured: 2 weeks post blastulation
Positive pregnancy rate
proportion of positive pregnancy tests per embryo transfer
Measured: approximately 9 days post embryo transfer
Sustained implantation rate
proportion of patients discharged with presence of a fetal heartbeat
Measured: 8-9 weeks gestational age or approximately 5-6 weeks post embryo transfer
Pregnancy loss rate
proportion of pregnancy patients who experience a loss of pregnancy
Measured: approximately 1-2 months post initial bHCG
Live birth rate
proportion of patients who deliver a live born infant
Measured: approximately 40 weeks gestation or 7 months post discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2024
- Study start31 May 2026
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Reproductive Medicine Associates of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jason Fransiak, MD, Principal investigator, Reproductive Medicine Associates of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06377917
- Sponsor's protocol ID
- 2304-BRG-057-JF
- Acronym
- IMPACT
- Status last verified
- Jun 2026
- First submitted
- 17 Apr 2024
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The IMPACT Trial: Investigating Micro-Manipulation Procedures for Assisted Hatching Timing
- ClinicalTrials.gov ID
- NCT06377917
- Acronym / sponsor ID
- IMPACT / 2304-BRG-057-JF
- Conditions
- Infertility
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Reproductive Medicine Associates of New JerseyUniversity, hospital or other
- Study start
- 31 May 2026 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2028 (estimated)
- First posted
- 22 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The proposed study aims to perform a split cohort study where each patient's cohort of fertilized zygotes, (two pronuclei or 2PNs) is split into two groups and randomized, thus allowing each patient to serve as their own control and decreasing confounding variables. Half of the cohort will proceed with the current standard of day 3 or cleavage assisted hatching and the other half of the cohort will receive the sequential hatching and trophectoderm biopsy procedure at the blastocyst stage of embryo development.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cleavage Stage Assisted Hatching (AH) | Other | Other: Laser Assisted HatchingCurrent standard of care. Day 3 or cleavage stage embryos will have the zona pellucida hatched with a laser. |
| Blastocyst Stage Assisted Hatching (AH) | Experimental | Other: Laser Assisted HatchingBlastocyst stage embryos on day 5,6 or 7 will have the zona pellucida hatched with a laser. |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Patients undergoing an IVF cycle with plan for subsequent FET of a single euploid embryo
- <4 2PNs prior to randomization
- Female partners age <42 years old at start of VOR cycle
- Normal ovarian reserve:
- BMI <38
Key exclusion criteria (10 listed)
- 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
- Donor oocyte cycles
- Gestational Carriers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laser Assisted HatchingRoutine assisted hatching procedure will be performed on both groups at the different embryo developmental phases. | Other | Blastocyst Stage Assisted Hatching (AH), Cleavage Stage Assisted Hatching (AH) |
Primary outcome
Blastulation Rate
Time frame: 1 week after vaginal oocyte retrieval (VOR)
Blastulation rate per 2 pronuclei (PN) in each group
7 secondary outcomes
Embryo morphologic grade
Time frame: 1 week post VOR
Timing of blastulation
Time frame: 1 week post VOR
Aneuploidy rate
Time frame: 2 weeks post blastulation
Positive pregnancy rate
Time frame: approximately 9 days post embryo transfer
Sustained implantation rate
Time frame: 8-9 weeks gestational age or approximately 5-6 weeks post embryo transfer
Pregnancy loss rate
Time frame: approximately 1-2 months post initial bHCG
Live birth rate
Time frame: approximately 40 weeks gestation or 7 months post discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jason Fransiak, MD principal investigator
Reproductive Medicine Associates of New Jersey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laser Assisted Hatching in people with Infertility, run by Reproductive Medicine Associates of New Jersey at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christine V Whitehead, MS, BSN, RN (19736562841, clinicalresearchteam@ivirma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blastulation Rate (time frame: 1 week after vaginal oocyte retrieval (VOR)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.