NCT06377917 Investigating Micro-Manipulation Procedures for Assisted Hatching Timing
| NCT ID | NCT06377917 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Reproductive Medicine Associates of New Jersey |
| Condition | Infertility |
| Study Type | INTERVENTIONAL |
| Enrollment | 75 participants |
| Start Date | 2026-05-31 |
| Primary Completion | 2027-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 75 participants in total. It began in 2026-05-31 with a primary completion date of 2027-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 aneuploidy (PGT-A) for treatment of their infertility.
Eligibility Criteria
Inclusion Criteria for participants: 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 for participants: 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
Contact & Investigator
Jason Fransiak, MD
PRINCIPAL INVESTIGATOR
Reproductive Medicine Associates of New Jersey
Frequently Asked Questions
Who can join the NCT06377917 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 42 Years, studying Infertility. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06377917 currently recruiting?
Yes, NCT06377917 is actively recruiting participants. Contact the research team at clinicalresearchteam@ivirma.com for enrollment information.
Where is the NCT06377917 trial being conducted?
This trial is being conducted at Marlton, United States.
Who is sponsoring the NCT06377917 clinical trial?
NCT06377917 is sponsored by Reproductive Medicine Associates of New Jersey. The principal investigator is Jason Fransiak, MD at Reproductive Medicine Associates of New Jersey. The trial plans to enroll 75 participants.