Phase 4
N=970
TiLE (Time Lapse Eeva) Clinical Trial
Fertility
Bottom Line
View on ClinicalTrials.gov: NCT02417441 ↗Enrolled (actual)
970
Serious AEs
—
Results posted
Apr 2019
Primary outcome: Primary: Implantation Rate — 30.1; 35.3 % of sacs per embryo transferred
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Eeva (Device)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Merck KGaA, Darmstadt, Germany
- Primary completion
- Feb 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Implantation Rate |
30.1; 35.3 | — |
| SECONDARY Clinical Pregnancy Rate |
41.0; 47.6 | — |
| SECONDARY Number of Subjects With Ongoing Pregnancy Status |
30; 11; 2; 1; 613; 313 | — |
| SECONDARY Multiple Pregnancy Rate |
6.4; 8.4 | — |
| SECONDARY Utilization Rate |
48.6; 49.6 | — |
| SECONDARY Spontaneous Miscarriage Rate |
NA; NA | — |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02417441). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.