Infertility
Conditions
Keywords
Preimplantation Embryo Development
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.
Interventions
OTHERDynamic 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.
Sponsors
Reproductive Medicine Associates of New Jersey
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 42 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blastulation Rate | 6 days post vaginal oocyte retrieval procedure | the number of blastocysts will be counted |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Pregnancy Rate | approximately 20-25 days post embryo transfer procedure | documented intrauterine pregnancy |
Countries
United States
Outcome results
None listed