Evaluation of the Impact of Monophasic vs. Sequential Media on the Reproductive Potential of Embryos Undergoing in Vitro Fertilization (IVF)
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Impact of monophasic vs. sequential media on the embryos produced from IVF on pregnancy rates
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 42 Years (Adult)
- Sex
- Female
- Accepts 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
- •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
Arms & Interventions
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 CCS & the best euploid embryo from each group will be transferred (DET). If there are only euploid embryos from one group, pt will have SET only (fresh or frozen)
Intervention: Comprehensive Chromosome Screening (Other)
Sequential 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 CCS & the best euploid embryo from each group will be transferred (DET). If there are only euploid embryos from one group, pt will have SET only (fresh or frozen)
Intervention: Comprehensive Chromosome Screening (Other)
Outcomes
Primary Outcomes
Impact of monophasic vs. sequential media on the embryos produced from IVF on pregnancy rates
Time Frame: 2 years
To assess if pregnancy rates are impacted by the type of culture media embryos produced by IVF are cultured in
Secondary Outcomes
No secondary outcomes reported