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Randomized Trial Comparing EmbryoScope With EmbryoScope+.

NCT ID: NCT03522350

Last Updated: 2019-05-31

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-06

Study Completion Date

2018-06-04

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Infertility

Keywords

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Infertility Embryo develpoment IVF ICSI EmbryoScope

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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EmbryoScope

Standard of care embryo incubator.

Group Type ACTIVE_COMPARATOR

EmbryoScope

Intervention Type DEVICE

Standard of care arm

EmbryoScope+

New experimental embryo incubator.

Group Type EXPERIMENTAL

EmbryoScope+

Intervention Type DEVICE

Experimental arm

Interventions

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EmbryoScope

Standard of care arm

Intervention Type DEVICE

EmbryoScope+

Experimental arm

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vitrolife

INDUSTRY

Sponsor Role collaborator

Weill Medical College of Cornell University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nikica Zaninovic, PhD

Role: PRINCIPAL_INVESTIGATOR

Center for Reproductive Medicine

Locations

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Center for Reproductive Medicine

New York, New York, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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1612017837

Identifier Type: -

Identifier Source: org_study_id