Study Overview

Details

NCTId: NCT02467725

Status: Completed

Condition: Infertility

Study Type: Interventional

Sponsor: Reproductive Medicine Associates of New Jersey

Study Description

Brief

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

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

Healthy Volunteers: No

Gender: Female

Min Age: 18 Years

Max Age: 42 Years

Contacts

Reproductive Medicine Associates of New Jersey

Basking Ridge

New Jersey

07920

United States