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

Merck KGaA (EMD Serono)

Status and phase

Terminated

Phase 4

Conditions

Infertility

Treatments

Device: Conventional incubator

Device: GERI+ incubator

Study type

Interventional

Funder types

Industry

Identifiers

NCT03164551

MS200497_0006

Details and patient eligibility

About

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.

Enrollment

408 patients

Sex

All

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

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