Phase 4
Completed N=970
TiLE (Time Lapse Eeva) Clinical Trial
Fertility
Source: ClinicalTrials.gov NCT02417441 ↗
Enrolled (actual)
970
Serious AEs
—
Results posted
Apr 2019
Primary outcomePrimary: Implantation Rate — 30.1; 35.3 % of sacs per embryo transferred
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
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 | — |
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. Informational only — not medical advice.