Randomized Trial Comparing EmbryoScope With EmbryoScope+.

Not Applicable

Terminated

• Conditions: Infertility
• Interventions: Device: EmbryoScope; Device: EmbryoScope+

• Registration Number: NCT03522350
• Lead Sponsor: Weill Medical College of Cornell University

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-09-06
• Study First Submitted: 2018-02-20
• Study First Submitted QC: 2018-05-09
• Study First Posted: 2018-05-11
• Primary Completion: 2018-06-04
• Study Completion: 2018-06-04
• Status Verified: 2019-05
• Results First Submitted: 2019-05-06
• Results First Submitted QC: 2019-05-06
• Last Update Submitted: 2019-05-06
• Results First Posted: 2019-05-31
• Last Update Posted: 2019-05-31

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 18

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EmbryoScope	EmbryoScope	Standard of care embryo incubator.
EmbryoScope+	EmbryoScope+	New experimental embryo incubator.

Primary Outcome Measures

Name	Time	Method
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+
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

Name	Time	Method
Pregnancy Rate	2 weeks post retrieval	Positive Bhcg
Implantation Rate	5-6 weeks post retrieval	Presence of a gestational sac

Trial Locations

Locations (1)

Center for Reproductive Medicine; 🇺🇸 New York, New York, United States