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

Completed · Not applicable

Conditions studied: Infertility

In brief

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.

Key facts

Study ID

NCT05483985

Run by

Alife Health

People needed

444

Starts

2022-07-11

Expected to finish

2024-12-20

Last updated by the study team

2026-06-15

Who can join

Age: 21 and older, up to 43. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• >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

You may not qualify if…

• 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

Where it is running

• CCRM — Menlo Park, California, United States
• Reproductive Science Center — San Ramon, California, United States
• IVF Florida Reproductive Associates — Margate, Florida, United States
• Center for Reproductive Medicine — Winter Park, Florida, United States
• Ovation Fertility — Austin, Texas, United States
• Aspire Fertility — San Antonio, Texas, United States
• Reproductive Care Center — Sandy City, Utah, United States

Full record on ClinicalTrials.gov

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