Evaluation of the Alife Hera System as an Adjunctive Tool for the Prioritization of Embryos Deemed Suitable for Transfer

To evaluate the clinical pregnancy rate (pregnancy defined as fetal heartbeat at 6-8 weeks) with the adjunctive use of the Hera System (Hera System used with traditional morphological grading) with embryos already deemed suitable for transfer compared to trained embryologists using standard morphology criteria alone.

To evaluate the performance and utilization of the Hera System as an adjunctive embryo grading and prioritization tool in an embryology lab setting with trained embryologists.

Inclusion criteria

• >21 and < 43 years of age
• Women undergoing in vitro fertilization treatment using their own eggs
• At least 8 eggs retrieved
• Fertilization using only ejaculated sperm including donor sperm (fresh or frozen)
• Single embryo transfer (SET)
• Willing to comply with study protocol and procedures and be able to speak English
• Willing to provide written informed consent

Exclusion criteria

• Gestational carriers
• Use of re-inseminated eggs
• Use of donor eggs
• History of cancer
• Fertilization using surgically removed sperm
• Transfer of multiple (more than one) embryos at once
• Participants undergoing IVF with intent to bank embryos (i.e. no intention of embryo transfer for at least 6 months following egg retrieval)
• Concurrent participation in another clinical study that might interfere with the study results in either study