FertilityPhase 4TiLENCT02417441
TiLE (Time Lapse Eeva) Clinical Trial
A Phase 4 study testing Eeva in people with Fertility, run by Merck KGaA, Darmstadt, Germany at 23 sites in 9 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fertility
- What is being tested?
- Eeva
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 976 participants
- Where
- 23 sitesin 9 countries
- Study dates
- 29 Jun 2015to 9 Feb 2017
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
23 sites in 9 countries.
23 sites in 9 countries
Canada4 sites
One Fertility
Burlington, Ontario
Cambrian Wellness Centre
Calgary, Alberta
ISIS Regional Fertility Clinic
Mississauga, Ontario
Mount Sinai Hospital
Toronto
Italy4 sites
Montichiari Università degli studi di Bresca
Montichiari
Istituto Clinico Humanitas
Rozzano
Università degli Studi Torino
Torino
Ospedale Versilia
Viareggio
France3 sites
CHRU - Hopital Jeanne de Flandres
Lille
Laboratoire Alphabio & Institut de Médecine de la Reproducti
Marseille
Hopital Hotel Dieu
Nantes
Germany3 sites
Universitatsklinik Schleswig-Holstein
Lübeck
Kinderwunsch Centrum München
Munich
MVZ Kinderwunschzentrum Wiesbaden GmbH
Wiesbaden
Spain3 sites
Clínica Vistahermosa
Alicante
Clinica Sagrada Familia
Barcelona
Hospital Universitario Virgen de las Nieves
Granada
United Kingdom3 sites
Bourn Hall
Cambridge
Birmingham Women's Health Care NHS Trust
Edgbaston
Homerton University Hospital
London
About this study
Official title: A Phase IV, Prospective, Randomized, Exploratory, Multicenter, Eeva™ Trial (Time Lapse Eeva - TiLE)
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.
Read the detailed 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.
- Conditions
- Fertility
- Being tested
- Eeva
- Keywords
- TiLE, Embryo Assessment, Pregnancy, Implantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EevaDevice
Embryos of subjects randomized in this group were assessed using Eeva System and morphological grading to identify optimal embryos for transfer.
| Study group | Role | What they receive |
|---|---|---|
| Early Embryo Viability Assessment + Morphological Grading | Experimental | 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. Receives: Device: Eeva |
| Morphological Grading | No intervention | Embryos of subjects randomized in this group were assessed only using morphological grading to identify optimal embryos for transfer. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implantation Rate
Implantation rate was calculated by dividing the number of intrauterine gestational sacs by the number of embryos transferred multiplied by 100.
Measured: Gestational Weeks 5 to 8
Secondary outcomes (5)
Clinical Pregnancy Rate
Clinical pregnancy was confirmed by the presence of a gestational sac with heartbeat as assessed by ultrasonography. Clinical pregnancy rate was measured as the number of clinical pregnancies divided by number of embryo transfer (ET) cycles multiplied by 100.
Measured: Gestational Weeks 5 to 8
Number of Subjects With Ongoing Pregnancy Status
Ongoing pregnancy was defined as having a positive fetal heart beat (FHB) as assessed by ultrasonography at gestational week 10-12. Number of subjects with ongoing pregnancy status has been reported, where "Yes" indicates participants with positive ongoing pregnancy status and "No" indicates participants with negative ongoing pregnancy status .
Measured: Gestational Weeks 10 to 12
Multiple Pregnancy Rate
Multiple pregnancy rate was defined as a clinical pregnancy with greater than equals to (>=) 2 fetal sacs as assessed by ultrasonography. Multiple Pregnancies rate was measured by number of multiple pregnancies divided by number of embryo transfer cycles multiplied by 100.
Measured: Gestational Weeks 5 to 8
Utilization Rate
Utilization rate was defined as the sum of number of transferred and frozen embryos divided by number of normally fertilized oocytes multiplied by 100.
Measured: Day 3 or Day 5/6 of embryo culture
Spontaneous Miscarriage Rate
Spontaneous miscarriage rate was measured by the number of spontaneous miscarriages as communicated during medical appointment or by telephone contact divided by number of clinical pregnancies multiplied by 100.
Measured: Gestational Weeks 10 to 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2015 (estimated)
- Study start29 Jun 2015
- Primary completion9 Feb 2017
- Study completion9 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for FertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 976 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck KGaA, Darmstadt, Germany
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Responsible, Study director, Merck KGaA, Darmstadt, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02417441
- Sponsor's protocol ID
- EMR700623_545
- Acronym
- TiLE
- Status last verified
- Jan 2020
- First submitted
- 10 Apr 2015
- Last updated
- 30 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IV, Prospective, Randomized, Exploratory, Multicenter, Eeva™ Trial (Time Lapse Eeva - TiLE)
- ClinicalTrials.gov ID
- NCT02417441
- Acronym / sponsor ID
- TiLE / EMR700623_545
- Conditions
- Fertility
- Keywords
- TiLE, Embryo Assessment, Pregnancy, Implantation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 976 participants (actual)
- Lead sponsor
- Merck KGaA, Darmstadt, GermanyIndustry (pharma, biotech, devices)
- Study start
- 29 Jun 2015 (actual)
- Primary completion
- 9 Feb 2017 (actual)
- Study completion
- 9 Feb 2017 (actual)
- First posted
- 15 Apr 2015 (estimated)
- Results
- Posted 29 Apr 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Embryo Viability Assessment + Morphological Grading | Experimental | Device: EevaEmbryos of subjects randomized in this group were assessed using Early Embryo Viability Assessment (Eeva) System and morphological grading to identify optimal embryos for transfer. |
| Morphological Grading | No intervention | –Embryos of subjects randomized in this group were assessed only using morphological grading to identify optimal embryos for transfer. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EevaEmbryos of subjects randomized in this group were assessed using Eeva System and morphological grading to identify optimal embryos for transfer. | Device | Early Embryo Viability Assessment + Morphological Grading |
Primary outcome
Implantation Rate
Time frame: Gestational Weeks 5 to 8
Implantation rate was calculated by dividing the number of intrauterine gestational sacs by the number of embryos transferred multiplied by 100.
5 secondary outcomes
Clinical Pregnancy Rate
Time frame: Gestational Weeks 5 to 8
Number of Subjects With Ongoing Pregnancy Status
Time frame: Gestational Weeks 10 to 12
Multiple Pregnancy Rate
Time frame: Gestational Weeks 5 to 8
Utilization Rate
Time frame: Day 3 or Day 5/6 of embryo culture
Spontaneous Miscarriage Rate
Time frame: Gestational Weeks 10 to 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Responsible study director
Merck KGaA, Darmstadt, Germany
23 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Eeva in people with Fertility, run by Merck KGaA, Darmstadt, Germany at 23 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in Canada, Italy, France, Germany, Spain and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implantation Rate (time frame: Gestational Weeks 5 to 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2020.