440 Participants Needed

Hera System for Infertility

(LOTUS Trial)

Recruiting at 6 trial locations
VS
Overseen ByVaishali Suraj, MS
Age: 18 - 65
Sex: Female
Trial Phase: Academic
Sponsor: Alife Health
Stay on Your Current MedsYou can continue your current medications while participating
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

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.

Are You a Good Fit for This Trial?

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)
See 3 more

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
See 5 more

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Device: Hera SystemExperimental Treatment1 Intervention
Group II: Traditional MorphologyActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Alife Health

Lead Sponsor

Trials
1
Recruited
440+
Unbiased ResultsWe believe in providing patients with all the options.
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