Sequential vs. Monophasic Media Impact Trial (SuMMIT)

Completed · Phase 4

Conditions studied: Infertility

In brief

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).

Key facts

Study ID

NCT01917240

Run by

Reproductive Medicine Associates of New Jersey

People needed

200

Starts

2013-07-01

Expected to finish

2016-05-01

Last updated by the study team

2016-06-22

Who can join

Age: 18 and older, up to 42. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Reproductive Medicine Associates of New Jersey — Basking Ridge, New Jersey, United States

Full record on ClinicalTrials.gov

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