Randomized Trial Comparing EmbryoScope With EmbryoScope+.

Randomized Controlled Trial Comparing EmbryoScope Time-Lapse System With the New Model EmbryoScope+.

The purpose of the study is to compare the current EmbryoScope Time-Lapse System being used in IVF which has become standard of care to the new model EmbryoScope to demonstrate that the EmbryoScope+ is as safe and reliable as the EmbryoScope.

Study Overview

• Status: Terminated
• Conditions: Infertility
• Intervention / Treatment: Device: EmbryoScope; Device: EmbryoScope+

Detailed Description

This is a randomized, controlled, single-center study in otherwise healthy infertile female subjects undergoing in vitro fertilization (IVF). The subjects recruited for this study will be among those patients who have been diagnosed with infertility and are planning to undergo IVF at the center where this study is being performed. The subjects will have undergone the usual informed consent procedure at the center.

Subjects will undergo ovarian stimulation, oocyte retrieval, IVF, and Intra Cytoplasmic Sperm Injection (ICSI) procedure following the center's usual procedures. At the time of retrieval, participant's oocytes will be randomly assigned to both groups for comparison: Standard EmbryoScope Time-Lapse system versus EmbryoScope+. The best quality embryos are selected for embryo transfer and the pregnancy outcome is evaluated.

"Best grade" embryos will be transferred regardless of EmbryoScope use. The standard EmbryoScope as well as the EmbryoScope+ monitor system as assigned during the randomization process will be used to observe the embryo development and document timing of embryo cleavages and morphology dynamics. Subjects will not be provided with the time- lapse images.

Endpoints will be Day 3 and Day 5/6 embryo development, implantation and pregnancy rate. The study is approximately 2 months, the estimated time it takes a physician to perform one IVF-ART treatment cycle. If embryos are frozen, the patient may be in the study until the time they choose to thaw the embryos or up to 1 year if they become pregnant.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • Center for Reproductive Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 40 years of age or younger (maternal)
• 65 years of age or younger (paternal)
• Fresh or frozen (including donor) sperm can be used
• Fresh oocytes only (including donor)
• Frozen embryos from this study can be included in the outcome portion of this study.
• Single or double Blastocyst transfer only

Exclusion Criteria:

• 3 or more previous failed cycles
• Sperm obtained by testicular biopsy
• Co-culture patients

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: EmbryoScope; Standard of care embryo incubator.	Device: EmbryoScope; Standard of care arm
Experimental: EmbryoScope+; New experimental embryo incubator.	Device: EmbryoScope+; Experimental arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Day 3 Embryos	Comparing number of embryos that fertilized normally and had development at Day 3 based on embryo grade between oocytes assigned to Standard EmbryoScope versus oocytes assigned to EmbryoScope+	Day 3 post retrieval
Number of Day 5 Embryos	Comparing the number pf embryos that developed at Day 5 based on embryo grade between oocytes assigned to Standard EmbryoScope versus oocytes assigned to EmbryoScope+	Day 5 post retrieval

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implantation Rate	Presence of a gestational sac	5-6 weeks post retrieval
Pregnancy Rate	Positive Bhcg	2 weeks post retrieval

Collaborators and Investigators

• Sponsor: Weill Medical College of Cornell University
• Collaborators: Vitrolife
• Investigators: Principal Investigator: Nikica Zaninovic, PhD, Center for Reproductive Medicine

Study record dates

Study Major Dates

• Study Start (Actual): September 6, 2017
• Primary Completion (Actual): June 4, 2018
• Study Completion (Actual): June 4, 2018

Study Registration Dates

• First Submitted: February 20, 2018
• First Submitted That Met QC Criteria: May 9, 2018
• First Posted (Actual): May 11, 2018

Study Record Updates

• Last Update Posted (Actual): May 31, 2019
• Last Update Submitted That Met QC Criteria: May 6, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: IVF; Infertility; ICSI; Embryo develpoment; EmbryoScope
• Additional Relevant MeSH Terms: Infertility
• Other Study ID Numbers: 1612017837

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes