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

  • STATUS
    Recruiting
  • End date
    Apr 11, 2023
  • participants needed
    230
  • sponsor
    Alife Health
Updated on 4 October 2022
in vitro fertilization
embryo transfer
single embryo transfers
Accepts healthy volunteers

Summary

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.

Description

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.

Details
Condition Infertility
Treatment Hera Score
Clinical Study IdentifierNCT05483985
SponsorAlife Health
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

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)
Participants undergoing IVF with intent of gender sex selection
Concurrent participation in another clinical study that might interfere with the study results in either study
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