TiLE (Time Lapse Eeva) Clinical Trial

NCT02417441 | Completed Phase 4 Results

• 1 other identifier: EMR700623_545
• Study Type: interventional
• Target: 976
• Locations: 9 countries
• Sites: 23

Brief 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.

Conditions

Fertility

Keywords

TiLE; Embryo Assessment; Pregnancy; Implantation

Outcome Measures

Primary Outcomes (1)

• Implantation Rate

  Implantation rate was calculated by dividing the number of intrauterine gestational sacs by the number of embryos transferred multiplied by 100.

  Gestational Weeks 5 to 8

Secondary Outcomes (5)

• Clinical Pregnancy Rate

  Gestational Weeks 5 to 8

• Number of Subjects With Ongoing Pregnancy Status

  Gestational Weeks 10 to 12

• Multiple Pregnancy Rate

  Gestational Weeks 5 to 8

• Utilization Rate

  Day 3 or Day 5/6 of embryo culture

• Spontaneous Miscarriage Rate

  Gestational Weeks 10 to 12

Other Outcomes (2)

• Eeva Conformity in Early Embryo Viability Assessment + Morphological Grading Group for Day 3 Embryo Transfer (ET)

  Day 3 of embryo culture

• Eeva Conformity in Early Embryo Viability Assessment + Morphological Grading Group for Day 5/6 Embryo Transfer (ET)

  Day 5/6 of embryo culture

Study Arms (2)

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.

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.

Interventions

Eeva DEVICE

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

Early Embryo Viability Assessment + Morphological Grading

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck KGaA, Darmstadt, Germany: lead

Study Sites (23)

Cambrian Wellness Centre

Calgary, Alberta, Canada

Location

One Fertility

Burlington, Ontario, Canada

Location

ISIS Regional Fertility Clinic

Mississauga, Ontario, Canada

Location

Mount Sinai Hospital

Toronto, Canada

Location

Rigshospitalet

Copenhagen, Denmark

Location

CHRU - Hopital Jeanne de Flandres

Lille, France

Location

Laboratoire Alphabio & Institut de Médecine de la Reproducti

Marseille, France

Location

Hopital Hotel Dieu

Nantes, France

Location

Universitatsklinik Schleswig-Holstein

Lübeck, Germany

Location

Kinderwunsch Centrum München

Munich, Germany

Location

MVZ Kinderwunschzentrum Wiesbaden GmbH

Wiesbaden, Germany

Location

Montichiari Università degli studi di Bresca

Montichiari, Italy

Location

Istituto Clinico Humanitas

Rozzano, Italy

Location

Università degli Studi Torino

Torino, Italy

Location

Ospedale Versilia

Viareggio, Italy

Location

Telemark hospital Porsgrunn

Skien, Norway

Location

Clínica Vistahermosa

Alicante, Spain

Location

Clinica Sagrada Familia

Barcelona, Spain

Location

Hospital Universitario Virgen de las Nieves

Granada, Spain

Location

Fertilitetscentrum Stockholm

Stockholm, Sweden

Location

Bourn Hall

Cambridge, United Kingdom

Location

Birmingham Women's Health Care NHS Trust

Edgbaston, United Kingdom

Location

Homerton University Hospital

London, United Kingdom

Location

Limitations and Caveats

Subgroup analysis revealed high incidence of Eeva noncompliance in the experimental arm and heterogeneous results across sites. Thus, no decisive conclusion can be made from this study.

Results Point of Contact

• Title: Communication Center
• Organization: Merck KGaA, Darmstadt, Germany

service@emdgroup.com

+49-6151-72-5200

Study Officials

• Medical Responsible

  Merck KGaA, Darmstadt, Germany

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2015
• First Posted: April 15, 2015
• Study Start: June 29, 2015
• Primary Completion: February 9, 2017
• Study Completion: February 9, 2017
• Last Updated: January 30, 2020
• Results First Posted: April 29, 2019

Record last verified: 2020-01

Locations

SE (1); DE (3); GB (3); CA (4); ES (3); FR (3); DK (1); IT (4); NO (1)