Hera System for Infertility

(LOTUS Trial)

Recruiting at 6 trial locations

Overseen By Vaishali Suraj, MS

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Alife Health

Disqualifiers: Cancer, Donor eggs, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

440 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial aims to see if using the Hera System can improve pregnancy rates in patients undergoing fertility treatments. The system helps embryologists choose the best embryos by providing extra information, potentially increasing the chances of pregnancy.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Eligibility Criteria

This trial is for women aged 21-43 undergoing in vitro fertilization with their own eggs, who have retrieved at least 8 eggs and are planning a single embryo transfer. They must be willing to follow the study's rules and speak English. Those using donor sperm are eligible, but not those using surgically removed sperm or donor eggs, intending to bank embryos, having cancer history, or aiming for gender selection.

Inclusion Criteria

Women undergoing in vitro fertilization treatment using their own eggs

At least 8 eggs retrieved

Single embryo transfer (SET)

Exclusion Criteria

Gestational carriers

Fertilization using surgically removed sperm

Concurrent participation in another clinical study that might interfere with the study results in either study

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Embryos are evaluated using the Hera System alongside traditional morphology grading to determine suitability for transfer

8 weeks

Regular visits as per embryology lab schedule

Follow-up

Participants are monitored for clinical pregnancy, defined as a fetal heartbeat at 6-8 weeks

8 weeks

Treatment Details

Interventions

• Hera Score

Trial Overview The trial is testing the Hera System as an additional method alongside traditional morphological grading of embryos suitable for transfer in IVF treatments. It aims to compare pregnancy rates (confirmed by fetal heartbeat) when using this system versus standard criteria used by embryologists alone.

Participant Groups

Group I: Device: Hera System Experimental Treatment 1 Intervention

For the Hera, the embryologist will use the consider both the standard morphology grade and the Hera System score on embryos that were already deemed suitable for transfer or freeze based on the standard morphology assessment to determine the most suitable embryo for transfer.

Group II: Traditional Morphology Active Control 1 Intervention

The embryo selection will be based on standard of care traditional morphology only.

Who Is Running the Clinical Trial?

Alife Health

Lead Sponsor

Trials

1

Recruited

440+