TiLE (Time Lapse Eeva) Clinical Trial

Fertility Clinical Trial

— TiLE  

Official title:

A Phase IV, Prospective, Randomized, Exploratory, Multicenter, Eeva™ Trial (Time Lapse Eeva - TiLE)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02417441
• Other study ID #: EMR700623_545
• Status: Completed
• Phase: Phase 4
• Start date: June 29, 2015
• Est. completion date: February 9, 2017

Study information

• Verified date: January 2020
• Source: Merck KGaA, Darmstadt, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 976
• Est. completion date: February 9, 2017
• Est. primary completion date: February 9, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Fertility

Intervention

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

Locations

Country	Name	City	State
Canada	One Fertility	Burlington	Ontario
Canada	Cambrian Wellness Centre	Calgary	Alberta
Canada	ISIS Regional Fertility Clinic	Mississauga	Ontario
Canada	Mount Sinai Hospital	Toronto
Denmark	Rigshospitalet	Copenhagen
France	CHRU - Hopital Jeanne de Flandres	Lille Cedex
France	Laboratoire Alphabio & Institut de Médecine de la Reproducti	Marseille
France	Hopital Hotel Dieu	Nantes
Germany	Universitatsklinik Schleswig-Holstein	Luebeck
Germany	Kinderwunsch Centrum München	Munich
Germany	MVZ Kinderwunschzentrum Wiesbaden GmbH	Wiesbaden
Italy	Montichiari Università degli studi di Bresca	Montichiari
Italy	Istituto Clinico Humanitas	Rozzano
Italy	Università degli Studi Torino	Torino
Italy	Ospedale Versilia	Viareggio
Norway	Telemark hospital Porsgrunn	Skien
Spain	Clínica Vistahermosa	Alicante
Spain	Clinica Sagrada Familia	Barcelona
Spain	Hospital Universitario Virgen de las Nieves	Granada
Sweden	Fertilitetscentrum Stockholm	Stockholm
United Kingdom	Bourn Hall	Cambridge
United Kingdom	Birmingham Women's Health Care NHS Trust	Edgbaston
United Kingdom	Homerton University Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
Merck KGaA, Darmstadt, Germany

Countries where clinical trial is conducted

Canada,  Denmark,  France,  Germany,  Italy,  Norway,  Spain,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Eeva Conformity in Early Embryo Viability Assessment + Morphological Grading Group for Day 3 Embryo Transfer (ET)	Eeva Conformity was reported as the number of subjects who were compliant to use Eeva in embryo assessment in the "Early Embryo Viability Assessment + morphological grading" group. Eeva-compliance subgroup refers to subjects whose embryos were assessed by embryologists following the recommendation of Eeva system and the instructions for use (IFU) of Eeva. Subgroup analysis revealed a high incidence of Eeva noncompliance in the experimental group, which compromised the quality of this study. Only "Early Embryo Viability Assessment + Morphological Grading" reporting arm was applicable for this outcome measure.	Day 3 of embryo culture
Other	Eeva Conformity in Early Embryo Viability Assessment + Morphological Grading Group for Day 5/6 Embryo Transfer (ET)	Eeva Conformity was reported as the number of subjects who were compliant to use Eeva in embryo assessment in the "Early Embryo Viability Assessment + morphological grading" group. Eeva-compliance subgroup refers to subjects whose embryos were assessed by embryologists following the recommendation of Eeva system and the IFU of Eeva. Subgroup analysis revealed a high incidence of Eeva noncompliance in the experimental group, which compromised the quality of this study. Only "Early Embryo Viability Assessment + Morphological Grading" reporting arm was applicable for this outcome measure.	Day 5/6 of embryo culture
Primary	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	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.	Gestational Weeks 5 to 8
Secondary	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 .	Gestational Weeks 10 to 12
Secondary	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.	Gestational Weeks 5 to 8
Secondary	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.	Day 3 or Day 5/6 of embryo culture
Secondary	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.	Gestational Weeks 10 to 12