Comparing the Outcomes of Intracytoplasmic Sperm Injection (ICSI) Using the Zona Pellucida-Bound Sperm Versus Conventional Manually Selected Sperm

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This study aims to assess the clinical significance of the intracytoplasmic sperm injection (ICSI) with zona-pellucida (ZP) bound sperm compared to ICSI with embryologist selected sperm for patients undergoing in vitro fertilization treatment of their infertility.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 41
Healthy Volunteers: f
View:

• Undergoing their first in vitro fertilization (IVF) cycle

• Electing single embryo transfer

• Electing preimplantation genetic testing for aneuploidy (PGT-A) of their embryos

• Female partners age \<42 years old at start of vaginal oocyte retrieval cycle, but \>18 years old.

• Normal ovarian reserve:

• Antimullerian hormone level (AMH) ≥ 1.2 ng/mL

• Antral follicle count (AFC) ≥ 8

• At least 4 mature oocytes (M2s) retrieved at the VOR procedure in order to randomize

• At least 1 immature oocyteretrieved at the VOR procedure to perform ZP binding co-incubation procedure

• Intention to transfer the morphological best quality, euploid, embryo at the frozen embryo transfer procedure

Locations
United States
California
Reproductive Medicine Associates of Northern California
RECRUITING
San Francisco
Contact Information
Primary
Caroline Zuckerman, BS, RN
clinicalresearchteam@ivirma.com
19736562841
Backup
Christine V Whitehead, BSN, RN
clinicalresearchteam@ivirma.com
19736562841
Time Frame
Start Date: 2023-11-03
Estimated Completion Date: 2026-06
Participants
Target number of participants: 200
Treatments
Experimental: ZP Bound Sperm Selection Oocyte Cohort
This is half of the patient's mature oocytes that will be inseminated via the ICSI procedure with sperm that has bound to the ZP of an immature oocyte.
Other: Routine Care: Embryologist Selected Sperm Oocyte Cohort
This is half of the patient's mature oocytes that will be inseminated via the ICSI procedure per routine with sperm that is subjectively selected by the embryologist (based on morphology and mobility characteristics). This is the current standard of care for ICSI.
Related Therapeutic Areas
Sponsors
Leads: IVI America

This content was sourced from clinicaltrials.gov