Infertility
Conditions
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.
Interventions
DEVICEHera Score
The device uses patient metadata (patient age, day of image capture) and a software algorithm to analyze features of the blastocyst morphology to provide adjunctive information that may predict further development of the embryo to clinical pregnancy after embryo transfer.
Sponsors
Alife Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomized Control Trial, 1:1 allocation in treatment and control group.
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 43 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Endpoint | up to 8 weeks | The primary study endpoint is clinical pregnancy - defined as a fetal heartbeat at 6-8 weeks. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of disagreement | week 1 | Incidence of disagreement for the top-ranked embryo between the Hera System and the embryologist. |
| User Experience | through study completion at 8 weeks | Assessment of Hera System usability as reported by the embryologist using a user questionnaire. |
Countries
United States
Outcome results
None listed