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EnMotion, Embryo's Natural Motion (EnMotion)

Primary Purpose

Infertility

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dynamic culture platform
Sponsored by
Reproductive Medicine Associates of New Jersey
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Infertility focused on measuring Preimplantation Embryo Development

Eligibility Criteria

18 Years - 42 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Reproductive Medicine Associates of New Jersey

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Dynamic Culture Platform

Static Culture

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Blastulation Rate
the number of blastocysts will be counted

Secondary Outcome Measures

Clinical Pregnancy Rate
documented intrauterine pregnancy

Full Information

First Posted
June 3, 2015
Last Updated
April 3, 2019
Sponsor
Reproductive Medicine Associates of New Jersey
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1. Study Identification

Unique Protocol Identification Number
NCT02467725
Brief Title
EnMotion, Embryo's Natural Motion
Acronym
EnMotion
Official Title
EnMotion, Embryo's Natural Motion: The Impact of Dynamic Culture on the Development of Useable Blastocysts
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
June 9, 2015 (Actual)
Primary Completion Date
May 31, 2018 (Actual)
Study Completion Date
October 15, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Reproductive Medicine Associates of New Jersey

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
Preimplantation Embryo Development

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dynamic Culture Platform
Arm Type
Experimental
Arm Description
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.
Arm Title
Static Culture
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Dynamic culture platform
Other Intervention Name(s)
NSSB-300 microvibration platform
Intervention Description
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.
Primary Outcome Measure Information:
Title
Blastulation Rate
Description
the number of blastocysts will be counted
Time Frame
6 days post vaginal oocyte retrieval procedure
Secondary Outcome Measure Information:
Title
Clinical Pregnancy Rate
Description
documented intrauterine pregnancy
Time Frame
approximately 20-25 days post embryo transfer procedure

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
42 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard T Scott, MD, HCLD
Organizational Affiliation
Reproductive Medicine Associates of New Jersey
Official's Role
Principal Investigator
Facility Information:
Facility Name
Reproductive Medicine Associates of New Jersey
City
Basking Ridge
State/Province
New Jersey
ZIP/Postal Code
07920
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
32044089
Citation
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.
Results Reference
derived

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EnMotion, Embryo's Natural Motion

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