NCT02467725

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 3, 2015

Completed
6 days until next milestone

Study Start

First participant enrolled

June 9, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 10, 2015

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2018

Completed
Last Updated

April 5, 2019

Status Verified

April 1, 2019

Enrollment Period

3 years

First QC Date

June 3, 2015

Last Update Submit

April 3, 2019

Conditions

Infertility

Keywords

Preimplantation Embryo Development

Outcome Measures

Primary Outcomes (1)

  • Blastulation Rate

    the number of blastocysts will be counted

    6 days post vaginal oocyte retrieval procedure

Secondary Outcomes (1)

  • Clinical Pregnancy Rate

    approximately 20-25 days post embryo transfer procedure

Study Arms (2)

Dynamic Culture Platform

EXPERIMENTAL

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

Static Culture

NO INTERVENTION

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.

Interventions

Dynamic culture platformOTHER

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.

Also known as: NSSB-300 microvibration platform
Dynamic Culture Platform

Eligibility Criteria

Age18 Years - 42 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Reproductive Medicine Associates of New Jersey

Basking Ridge, New Jersey, 07920, United States

Location

Related Publications (1)

  • 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.

    PMID: 32044089DERIVED

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Richard T Scott, MD, HCLD

    Reproductive Medicine Associates of New Jersey

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 3, 2015

First Posted

June 10, 2015

Study Start

June 9, 2015

Primary Completion

May 31, 2018

Study Completion

October 15, 2018

Last Updated

April 5, 2019

Record last verified: 2019-04

Locations

US(1)