Status:
COMPLETED
Sequential vs. Monophasic Media Impact Trial (SuMMIT)
Lead Sponsor:
Reproductive Medicine Associates of New Jersey
Conditions:
Infertility
Eligibility:
FEMALE
18-42 years
Phase:
PHASE4
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2016
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT01917240
Start Date
July 1 2013
End Date
May 1 2016
Last Update
June 22 2016
Active Locations (1)
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1
Reproductive Medicine Associates of New Jersey
Basking Ridge, New Jersey, United States, 07920