EnMotion, Embryo's Natural Motion (EnMotion)

EnMotion, Embryo's Natural Motion: The Impact of Dynamic Culture on the Development of Useable Blastocysts

The purpose of the study is to determine if a dynamic embryo microenvironment impacts embryo development and reproductive potential in comparison to static culture.

Study Overview

• Status: Completed
• Conditions: Infertility
• Intervention / Treatment: Other: Dynamic culture platform

Detailed Description

The proposed research design is a prospective randomized control trial. Patients with normal ovarian reserve, who would be expected to have reasonable outcomes after in vitro fertilization, will serve as the subjects. Embryos from the same patient will be randomized to either static or dynamic culture. They will then be cultured to the blastocyst stage of embryo development and biopsied for preimplantation genetic screening. The best chromosomally normal embryo from each culture group will be selected and transferred to complete a double embryo transfer in a subsequent frozen embryo transfer cycle the following month.

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Basking Ridge, New Jersey, United States, 07920
      • Reproductive Medicine Associates of New Jersey

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 42 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Infertile women seeking in vitro fertilization treatment with aneuploidy screening
• Patient is eligible for a two-embryo transfer in compliance with ASRM guidelines
• Patient able to undergo a frozen embryo transfer cycle the month following the vaginal oocyte retrieval procedure
• Maximum day 3 Follicle-stimulating hormone level (≤12 IU/L)
• Anti-mullerian hormone level ≥ 1.2g/mL, tested within previous year
• ≤1 prior failed IVF cycle
• Male partner with >100,000 total motile spermatozoa per ejaculate (donor sperm acceptable)
• Body Mass Index ≤ 32
• Antral Follicle Count ≥ 8

Exclusion Criteria:

• Diagnosis of endometrial insufficiency defined as a prior cycle with maximal endometrial thickness ≤ 6mm, abnormal endometrial pattern (failure to attain a trilaminar appearance), persistent endometrial fluid
• Use of oocyte donation
• Use of gestational carrier
• Medical contraindication to double embryo transfer
• Use of testicular aspiration or biopsy procedures to obtain sperm
• Presence of a hydrosalpinx that communicates with the endometrial cavity
• Any contraindications to undergoing in vitro fertilization or gonadotropin stimulation
• Single gene disorder requiring more detailed embryo genetic analysis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dynamic Culture Platform; Embryos randomized to the dynamic arm will be placed on the NSSB-300 microvibration platform within the designated incubator. The platform will vibrate at a strength setting of 4 for 5 seconds every 60 minutes. The embryos will be placed on the platform at the two pronucleur stage of development and remain on the platform until the blastocyst stage of development at which time the embryos will be biopsied for preimplantation genetic screening and frozen.	Other: Dynamic culture platform; Patients will have their cohort of embryos split in half. Half will be cultured in the dynamic platform and the other half cultured in static.; Other Names: NSSB-300 microvibration platform
No Intervention: Static Culture; The embryos randomized to the static or control arm of the study will be placed directly into the incubator and will not have any additional vibration, per routine care. The embryos will be placed in the incubator at the two pronucleur stage of development and remain in the incubator until the blastocyst stage of development at which time the embryos will be biopsied for preimplantation genetic screening and frozen.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blastulation Rate	the number of blastocysts will be counted	6 days post vaginal oocyte retrieval procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Pregnancy Rate	documented intrauterine pregnancy	approximately 20-25 days post embryo transfer procedure

Collaborators and Investigators

• Sponsor: Reproductive Medicine Associates of New Jersey
• Investigators: Principal Investigator: Richard T Scott, MD, HCLD, Reproductive Medicine Associates of New Jersey

Publications and helpful links

General Publications

• Juneau CR, Tiegs AW, Franasiak JM, Goodman LR, Whitehead C, Patounakis G, Scott RT Jr. Embryo's Natural Motion (enMotion): a paired randomized controlled trial evaluating a dynamic embryo culture system. Fertil Steril. 2020 Mar;113(3):578-586.e1. doi: 10.1016/j.fertnstert.2019.09.043. Epub 2020 Feb 7.

Study record dates

Study Major Dates

• Study Start (Actual): June 9, 2015
• Primary Completion (Actual): May 31, 2018
• Study Completion (Actual): October 15, 2018

Study Registration Dates

• First Submitted: June 3, 2015
• First Submitted That Met QC Criteria: June 9, 2015
• First Posted (Estimate): June 10, 2015

Study Record Updates

• Last Update Posted (Actual): April 5, 2019
• Last Update Submitted That Met QC Criteria: April 3, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Preimplantation Embryo Development
• Additional Relevant MeSH Terms: Infertility
• Other Study ID Numbers: RMA-2015-01