EnMotion, Embryo's Natural Motion

Infertility Clinical Trial

— EnMotion  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02467725
• Other study ID #: RMA-2015-01
• Status: Completed
• Phase: N/A
• Start date: June 9, 2015
• Est. completion date: October 15, 2018

Study information

• Verified date: April 2019
• Source: Reproductive Medicine Associates of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: October 15, 2018
• Est. primary completion date: May 31, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 42 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United States	Reproductive Medicine Associates of New Jersey	Basking Ridge	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Reproductive Medicine Associates of New Jersey

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blastulation Rate	the number of blastocysts will be counted	6 days post vaginal oocyte retrieval procedure
Secondary	Clinical Pregnancy Rate	documented intrauterine pregnancy	approximately 20-25 days post embryo transfer procedure