Is Day 3 vs Day 5-7 Assisted Hatching Helpful in IVF with PGT-A

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study uses a split-cohort design where each participant's fertilized embryos are randomized to either Day 3 cleavage-stage assisted hatching or sequential Day 5-7 blastocyst-stage hatching with TE biopsy. Each patient serves as her own control to reduce confounding. Laser-assisted hatching is the intervention under evaluation. Eligible participants are those undergoing an IVF cycle with plans for a single euploid embryo transfer after PGT-A, with specific age and ovarian reserve criteria, and BMI under 38. The study aims to determine the clinical significance of the different timing of assisted hatching in the context of euploid embryo transfer.

Why it matters

Who can join: the full rules

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

Where it's running

• Reproductive Medicine Associates of New Jersey
  Marlton, New Jersey, United States Recruiting

Study contacts

• Principal investigator: Jason Fransiak, MD — Reproductive Medicine Associates of New Jersey
• Study coordinator: Christine V Whitehead, MS, BSN, RN
• Email: clinicalresearchteam@ivirma.com
• Phone: 19736562841

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.