Randomized Trial Comparing EmbryoScope With EmbryoScope+.

• Sponsor: Weill Medical College of Cornell University (Other)
• Overall Status: Terminated
• CT.gov ID: NCT03522350
• Collaborator: Vitrolife (Industry)
• Enrollment: 18
• Location: 1
• Arms: 2
• Actual Duration (Months): 8.9
• Patients Per Site Per Month: 2

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Infertility	Device: EmbryoScope; Device: EmbryoScope+	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 18 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Randomized Controlled Trial Comparing EmbryoScope Time-Lapse System With the New Model EmbryoScope+.
• Actual Study Start Date: Sep 6, 2017
• Actual Primary Completion Date: Jun 4, 2018
• Actual Study Completion Date: Jun 4, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Number of Day 3 Embryos [Day 3 post retrieval]

   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+

2. Number of Day 5 Embryos [Day 5 post retrieval]

   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+

Secondary Outcome Measures

1. Implantation Rate [5-6 weeks post retrieval]

   Presence of a gestational sac

2. Pregnancy Rate [2 weeks post retrieval]

   Positive Bhcg

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Center for Reproductive Medicine	New York	New York	United States	10065

Sponsors and Collaborators

• Weill Medical College of Cornell University
• Vitrolife

Investigators

• Principal Investigator: Nikica Zaninovic, PhD, Center for Reproductive Medicine

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - May 17, 2018

More Information

Publications

None provided.

• Responsible Party: Weill Medical College of Cornell University
• ClinicalTrials.gov Identifier: NCT03522350
• Other Study ID Numbers: 1612017837
• First Posted: May 11, 2018
• Last Update Posted: May 31, 2019
• Last Verified: May 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Keywords provided by Weill Medical College of Cornell University: Infertility; Embryo develpoment; IVF; ICSI; EmbryoScope
• Additional relevant MeSH terms: Infertility

Study Results

Participant Flow

Recruitment Details	Patients undergoing IVF were be recruited to participate in the study. Those agreeing to participate consented to have their embryos incubated in the new Embryoscope+ as opposed to the current one being used as standard of care.
Pre-assignment Detail	18 subjects will undergo IVF. Participant's oocytes at retrieval will be randomly assigned to both groups for comparison: Standard EmbryoScope 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.

Arm/Group Title	Embryoscope +	Embryoscope
Arm/Group Description	Embryoscope +	Embryoscope
Period Title: Overall Study
STARTED	18	18
COMPLETED	18	18
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	All Study Participants
Arm/Group Description	This includes all participants - oocytes were randomized to standard of care embryo incubator and experimental Embryoscope +
Overall Participants	18
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	18 100%
>=65 years	0 0%
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	33.6
Sex: Female, Male (Count of Participants)
Female	18 100%
Male	0 0%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	1 5.6%
Not Hispanic or Latino	17 94.4%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	4 22.2%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	2 11.1%
White	10 55.6%
More than one race	0 0%
Unknown or Not Reported	2 11.1%
Region of Enrollment (Count of Participants)
United States	18 100%

Outcome Measures

1. Primary Outcome

Title	Number of Day 3 Embryos
Description	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+
Time Frame	Day 3 post retrieval

Outcome Measure Data

Analysis Population Description

Number of day 3 embryos compared in both groups

Arm/Group Title	Embryoscope +	Embryoscope
Arm/Group Description	Embryoscope +	Embryoscope
Measure Participants	18	18
Measure embryos	115	116
Count of Units [embryos]	42	42

2. Primary Outcome

Title	Number of Day 5 Embryos
Description	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+
Time Frame	Day 5 post retrieval

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Embryoscope +	Embryoscope
Arm/Group Description	Embryoscope +	Embryoscope
Measure Participants	18	18
Measure embryos	115	116
Count of Units [embryos]	43	51

3. Secondary Outcome

Title	Implantation Rate
Description	Presence of a gestational sac
Time Frame	5-6 weeks post retrieval

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Embryoscope +	Embryoscope
Arm/Group Description	Embryoscope +	Embryoscope
Measure Participants	18	18
Count of Participants [Participants]	3 16.7%	9 NaN

4. Secondary Outcome

Title	Pregnancy Rate
Description	Positive Bhcg
Time Frame	2 weeks post retrieval

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Embryoscope +	Embryoscope
Arm/Group Description	Embryoscope +	Embryoscope
Measure Participants	18	18
Count of Participants [Participants]	4 22.2%	9 NaN

Adverse Events

Time Frame	3 months
Arm/Group Title	All Participants Enrolled
Arm/Group Description	All participants enrolled and randomized to Embryoscope and Embryoscope+
All Cause Mortality
	All Participants Enrolled
	Affected / at Risk (%)	# Events
Total	0/18 (0%)
Serious Adverse Events
	All Participants Enrolled
	Affected / at Risk (%)	# Events
Total	0/18 (0%)
Other (Not Including Serious) Adverse Events
	All Participants Enrolled
	Affected / at Risk (%)	# Events
Total	0/18 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.