Investigating Micro-Manipulation Procedures for Assisted Hatching Timing

NCT ID: NCT06377917

Last Updated: 2025-02-07

Study Results

Results pending

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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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-30

Study Completion Date

2027-05-31

Brief Summary

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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

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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

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Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

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.

Group Type OTHER

Laser Assisted Hatching

Intervention Type OTHER

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.

Group Type EXPERIMENTAL

Laser Assisted Hatching

Intervention Type OTHER

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

1. All patients who do not voluntarily give their written consent for participation
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
Minimum Eligible Age

18 Years

Maximum Eligible Age

42 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Reproductive Medicine Associates of New Jersey

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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United States

Central Contacts

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Christine V Whitehead, MS, BSN, RN

Role: CONTACT

19736562841

Caroline Zuckerman, BS, RN

Role: CONTACT

19736562841

Facility Contacts

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Christine V Whitehead, MS, BSN, RN

Role: primary

19736562841

Caroline Zuckerman, BS, RN

Role: backup

19736562841

Other Identifiers

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2304-BRG-057-JF

Identifier Type: -

Identifier Source: org_study_id

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