TerminatedPhase 4

TICON-Day 3, Time Lapse Versus Conventional Method in Day 3 Embryo Culture and Assessment

Stopped: Participant enrollment has remained significantly behind plan despite increased site enrollment activity.

Canada, Denmark, France408 participantsStarted 2018-04-16

Plain-language summary

The main purpose of the study was to evaluate the overall clinical value of GERI+ as an integrated embryo culture and assessment system, providing an undisturbed culture environment, continuous monitoring of embryo development and automated scoring using a predictive algorithm.

Who can participate

Age range

18 Years – 40 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Couples with less than or equal to (\<= ) two failed fresh In Vitro Fertilization/Intracytoplasmic Sperm Injection (IVF/ICSI) embryo transfer cycles * Age greater than or equal to (\>=) 18 and \<= 40 years * Body mass index (BMI): 18-30 kilogram per meter square (kg/m2) * Normal uterine cavity under ultrasound * Participant and her husband/partner must have read and signed the Informed Consent form (ICF) * At least four normally fertilized oocytes (2Pronuclear stage (PN)) in the current cycle Exclusion Criteria: * Male with non-ejaculated sperm * Participants with abnormal, undiagnosed gynecological bleeding or with genitourinary malformations * Participants with any contraindication to Controlled Ovarian Stimulation (COS) for Assisted Reproductive Technologies (ART) or to gonadotropins * Planned "freeze all" cycle (oocytes or embryos) * Planned preimplantation genetic screening (PGS) or Pre-implantation genetic diagnosis (PGD) cycle * Concurrent participation in another clinical study

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Clinical Pregnancy Rate With Positive Fetal Heart Beat (FHB)

Timeframe: Gestation Weeks 6 to 8

Trial details

NCT IDNCT03164551

SponsorMerck KGaA, Darmstadt, Germany

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-11-20

Results submitted2020-11-06

View on ClinicalTrials.gov More Infertility trials

Who can participate

Age range

18 Years – 40 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.