EnMotion, Embryo's Natural Motion

NCT ID: NCT02467725

Last Updated: 2019-04-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-09
• Study Completion Date: 2018-10-15

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.

Conditions

Infertility

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Dynamic culture platform

Intervention Type: 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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Other Intervention Names

NSSB-300 microvibration platform

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 42 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Reproductive Medicine Associates of New Jersey

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Richard T Scott, MD, HCLD

Role: PRINCIPAL_INVESTIGATOR

Reproductive Medicine Associates of New Jersey

Locations

Reproductive Medicine Associates of New Jersey

Basking Ridge, New Jersey, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 32044089 (View on PubMed)

Other Identifiers

RMA-2015-01

Identifier Type: -

Identifier Source: org_study_id