Investigating Micro-Manipulation Procedures for Assisted Hatching Timing

ConditionInfertility
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-42
SponsorReproductive Medicine Associates of New Jersey

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

AMH ≥ 1.2 ng/mL

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Laser Assisted Hatching

    Other intervention

    Routine assisted hatching procedure will be performed on both groups at the different embryo developmental phases.

Treatment groups

75 Participants
are divided into 2 treatment groups
Group A: Cleavage Stage Assisted Hatching (AH)Other 1 intervention
Group B: Blastocyst Stage Assisted Hatching (AH)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Blastulation Rate

Blastulation rate per 2 pronuclei (PN) in each group

Time frame
1 week after vaginal oocyte retrieval (VOR)

Secondary outcomes

1

Embryo morphologic grade

Gardner and Modified Gardner grading system will be used

Time frame
1 week post VOR
2

Timing of blastulation

proportion of blastocysts that blastulate on day 5,6 or 7

Time frame
1 week post VOR
3

Aneuploidy rate

Rates of whole chromosome positive and negative preimplantation genetic testing (PGT-A) results

Time frame
2 weeks post blastulation
4

Positive pregnancy rate

proportion of positive pregnancy tests per embryo transfer

Time frame
approximately 9 days post embryo transfer

Other outcomes

Sponsors and contacts

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