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OpenTrials
Completed

NCT Number: NCT02467725

EnMotion, Embryo's Natural Motion

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

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Key information

Age range

18 year–42 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Reproductive Medicine Associates of New Jersey

Basking Ridge, New Jersey, 07920, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dynamic culture platform

Other

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

Primary outcomes

  1. Blastulation Rate

    Time frame: 6 days post vaginal oocyte retrieval procedure

    the number of blastocysts will be counted

Secondary outcomes

  1. Clinical Pregnancy Rate

    Time frame: approximately 20-25 days post embryo transfer procedure

    documented intrauterine pregnancy

Sponsors and collaborators

Lead sponsor

Reproductive Medicine Associates of New Jersey

Other

Registry information

Official study title

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

Acronym: EnMotion

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Jun 10, 2015
Registry last updated
Apr 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.