Clinical trial NCT02467725: EnMotion, Embryo's Natural Motion
Official title: EnMotion, Embryo's Natural Motion: The Impact of Dynamic Culture on the Development of Useable Blastocysts
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility
Keywords: Preimplantation Embryo Development
Lead sponsor: Reproductive Medicine Associates of New Jersey
Sponsor class: OTHER
First posted: 2015-06-10
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Blastulation Rate
timeFrame: 6 days post vaginal oocyte retrieval procedure
Secondary outcomes:
measure: Clinical Pregnancy Rate
timeFrame: approximately 20-25 days post embryo transfer procedure
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Reproductive Medicine Associates of New Jersey
state: New Jersey
Study officials:
affiliation: Reproductive Medicine Associates of New Jersey
name: Richard T Scott, MD, HCLD
role: PRINCIPAL_INVESTIGATOR
References:
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.