Clinical trial NCT05483985: Evaluation of the Alife Hera System as an Adjunctive Tool for the Prioritization of Embryos Deemed Suitable for Transfer
Official title: Evaluation of the Alife Hera System as an Adjunctive Tool for the Prioritization of Embryos Deemed Suitable for Transfer: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Infertility
Lead sponsor: Alife Health
Sponsor class: INDUSTRY
First posted: 2022-08-02
Enrollment: 440
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 43
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Control Trial, 1:1 allocation in treatment and control group.
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

1. \>21 and \< 43 years of age
2. Women undergoing in vitro fertilization treatment using their own eggs
3. At least 8 eggs retrieved
4. Fertilization using only ejaculated sperm including donor sperm (fresh or frozen)
5. Single embryo transfer (SET)
6. Willing to comply with study protocol and procedures and be able to speak English
7. Willing to provide written informed consent

Exclusion Criteria:

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

Primary outcomes:
measure: Primary Endpoint
timeFrame: up to 8 weeks
Secondary outcomes:
measure: Incidence of disagreement
timeFrame: week 1
measure: User Experience
timeFrame: through study completion at 8 weeks
Other outcomes:
Locations:
city: Menlo Park
country: United States
facility: CCRM
state: California
city: San Ramon
country: United States
facility: Reproductive Science Center
state: California
city: Margate
country: United States
facility: IVF Florida Reproductive Associates
state: Florida
city: Winter Park
country: United States
facility: Center for Reproductive Medicine
state: Florida
city: Austin
country: United States
facility: Ovation Fertility
state: Texas
city: San Antonio
country: United States
facility: Aspire Fertility
state: Texas
city: Sandy
country: United States
facility: Reproductive Care Center
state: Utah
Study officials:
References: