Investigating Micro-Manipulation Procedures for Assisted Hatching Timing
NCT ID: NCT06377917
Last Updated: 2025-02-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
75 participants
INTERVENTIONAL
2025-04-30
2027-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
TRIPLE
Study Groups
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Cleavage Stage Assisted Hatching (AH)
Current standard of care. Day 3 or cleavage stage embryos will have the zona pellucida hatched with a laser.
Laser Assisted Hatching
Routine assisted hatching procedure will be performed on both groups at the different embryo developmental phases.
Blastocyst Stage Assisted Hatching (AH)
Blastocyst stage embryos on day 5,6 or 7 will have the zona pellucida hatched with a laser.
Laser Assisted Hatching
Routine assisted hatching procedure will be performed on both groups at the different embryo developmental phases.
Interventions
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Laser Assisted Hatching
Routine assisted hatching procedure will be performed on both groups at the different embryo developmental phases.
Eligibility Criteria
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Inclusion Criteria
2. \<4 2PNs prior to randomization
3. Female partners age \<42 years old at start of VOR cycle
4. Normal ovarian reserve:
1. AMH ≥ 1.2 ng/mL
2. AFC ≥ 8
3. FSH ≤ 12IU/L
5. BMI \<38
6. Patients who desire to transfer the best quality embryo for their embryo transfer.
Exclusion Criteria
2. Patients with a prior failed IVF cycle - defined as no blastocysts
3. Patients with a history of more than one failed euploid embryo transfer
4. Donor oocyte cycles
5. Gestational Carriers
6. Male partner with \<100,000 total motile spermatozoa per ejaculate (donor sperm is acceptable)
7. Use of surgical procedures to obtain sperm
8. Communicating hydrosalpinges without a plan for surgical correct prior to frozen embryo transfer
9. Endometrial Insufficiency, as defined by a prior cycle with maximal endometrial thickness \<6mm,), or persistent endometrial fluid
10. Single gene disorders, chromosomal translocations, or any other disorders requiring a more detailed embryo genetic analysis than standard PGT-A
18 Years
42 Years
FEMALE
No
Sponsors
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Reproductive Medicine Associates of New Jersey
OTHER
Responsible Party
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Principal Investigators
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Jason Fransiak, MD
Role: PRINCIPAL_INVESTIGATOR
Reproductive Medicine Associates of New Jersey
Locations
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Reproductive Medicine Associates of New Jersey
Marlton, New Jersey, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2304-BRG-057-JF
Identifier Type: -
Identifier Source: org_study_id
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