Sequential vs. Monophasic Media Impact Trial (SuMMIT)
- Conditions
- Infertility
- Registration Number
- NCT01917240
- Lead Sponsor
- Reproductive Medicine Associates of New Jersey
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 200
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Reproductive Medicine Associates of New Jersey
🇺🇸Basking Ridge, New Jersey, United States
Reproductive Medicine Associates of New Jersey🇺🇸Basking Ridge, New Jersey, United States