Investigating Micro-Manipulation Procedures for Assisted Hatching Timing

Infertility Clinical Trial

— IMPACT  

Official title:

The IMPACT Trial: Investigating Micro-Manipulation Procedures for Assisted Hatching Timing

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06377917
• Other study ID #: 2304-BRG-057-JF
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2024
• Est. completion date: May 2026

Study information

• Verified date: April 2024
• Source: Reproductive Medicine Associates of New Jersey
• Contact: Christine V Whitehead, MS, BSN, RN
• Phone: 19736562841
• Email: clinicalresearchteam[@]ivirma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 75
• Est. completion date: May 2026
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 42 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility

Intervention

Other:
• Laser Assisted Hatching
Routine assisted hatching procedure will be performed on both groups at the different embryo developmental phases.

Locations

Country	Name	City	State
United States	Reproductive Medicine Associates of New Jersey	Marlton	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Reproductive Medicine Associates of New Jersey

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blastulation Rate	Blastulation rate per 2 pronuclei (PN) in each group	1 week after vaginal oocyte retrieval (VOR)
Secondary	Embryo morphologic grade	Gardner and Modified Gardner grading system will be used	1 week post VOR
Secondary	Timing of blastulation	proportion of blastocysts that blastulate on day 5,6 or 7	1 week post VOR
Secondary	Aneuploidy rate	Rates of whole chromosome positive and negative preimplantation genetic testing (PGT-A) results	2 weeks post blastulation
Secondary	Positive pregnancy rate	proportion of positive pregnancy tests per embryo transfer	approximately 9 days post embryo transfer
Secondary	Sustained implantation rate	proportion of patients discharged with presence of a fetal heartbeat	8-9 weeks gestational age or approximately 5-6 weeks post embryo transfer
Secondary	Pregnancy loss rate	proportion of pregnancy patients who experience a loss of pregnancy	approximately 1-2 months post initial bHCG
Secondary	Live birth rate	proportion of patients who deliver a live born infant	approximately 40 weeks gestation or 7 months post discharge