Infertility
Conditions
Keywords
Monophasic, Sequential, Media
Brief summary
To evaluate the impact of two FDA approved culture media on potential of human embryos resulting from IVF (sequential & monophasic media). Half of each patient's embryos will be randomly assigned to grow in monophasic media & the other half in sequential media. All embryos will undergo Comprehensive Chromosome Screening (CCS) & the best euploid embryo from each group will be transferred resulting in a double embryo transfer (DET). If there are only euploid embryos from one group, patient will have single embryo transfer (SET)(fresh or frozen).
Interventions
On day 5 or 6 of embryo development, all embryos will undergo a trophectoderm biopsy using the standardized technique, as according to standard laboratory protocol and without regard to study. Comprehensive Chromosome Screening (CCS) results will be available by the morning of day 6 if embryos are suitable for a fresh transfer which is the routine in our program.
Sponsors
Reproductive Medicine Associates of New Jersey
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 42 Years
Healthy volunteers
No
Inclusion criteria
* Patient undergoing IVF/CCS (no PGD banking) * Patient meets ASRM guidelines for Double Embryo Transfer (DET) * Donor Sperm OK * AMH ≥ 1.2 * FSH ≤ 12 * BAFC ≥12 * Max 1 prior failed IVF cycle for patients 35-45 years old * Patient \<35 years old MUST have 1 prior failed IVF cycle
Exclusion criteria
* Chronic endometrial insufficiency * Use of oocyte donor or gestational carriers * Medical contraindications to Double Embryo Transfer (DET) * Male Factor (\<100,000 sperm or surgical sperm) * Communicating hydrosalpinx (on HSG) * Single gene disorders or sex selection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Impact of monophasic vs. sequential media on the embryos produced from IVF on pregnancy rates | 2 years | To assess if pregnancy rates are impacted by the type of culture media embryos produced by IVF are cultured in |
Countries
United States
Outcome results
None listed