TiLE (Time Lapse Eeva) Clinical Trial

Merck KGaA (EMD Serono)

Status and phase: Completed; Phase 4

Conditions: Fertility

Treatments: Device: Eeva

Study type: Interventional

Funder types: Industry

Identifiers

NCT02417441

EMR700623_545

Details and patient eligibility

About

The purpose of the study was to explore the added value of adjunctive use of Early Embryo Viability Assessment (Eeva) with morphological grading in identifying optimal embryos for transfer.

Full description

This study is a Phase IV, open label, prospective, randomized, exploratory, multicenter study. Subjects were randomized in 2:1 ratio to two treatment groups: in the experimental group, embryos were assessed for embryo transfer (ET) with Eeva and morphological grading, while in the control group embryos were assessed with morphological grading only.

Enrollment: 976 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• All infertile subjects treated with In vitro fertilization (IVF)/intracytoplasmic sperm injection (ICSI)
• Subject age less than or equal to (<=) 40 years
• Less than or equal to (<=) 3 failed IVF/ICSI cycles
• At least 4 normally fertilized eggs (2 pronuclei [2PN]) in current cycle
• Normal uterine cavity
• Fertilization using only ejaculated sperm (fresh or frozen)
• Subject must have read and signed the Informed Consent Form

Exclusion criteria

• Have clinically significant systemic disease
• Have abnormal, undiagnosed gynecological bleeding
• Have any contraindication to Controlled Ovarian Stimulation (COS) for assisted reproductive technologies (ART) and to gonadotropins to be used in ART
• Egg donor cycle
• Planned "freeze all" cycle (oocytes or embryos)
• Concurrent participation in another clinical trial

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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976 participants in 2 patient groups

Early Embryo Viability Assessment + Morphological Grading

Experimental group

Description:

Embryos of subjects randomized in this group were assessed using Early Embryo Viability Assessment (Eeva) System and morphological grading to identify optimal embryos for transfer.

Treatment:

Device: Eeva

Morphological Grading

No Intervention group

Description:

Embryos of subjects randomized in this group were assessed only using morphological grading to identify optimal embryos for transfer.