Infertility Clinical Trial
— SuMMITOfficial title:
Evaluation of the Impact of Monophasic vs. Sequential Media on the Reproductive Potential of Embryos Undergoing in Vitro Fertilization (IVF)
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).
Status | Completed |
Enrollment | 200 |
Est. completion date | May 2016 |
Est. primary completion date | May 2016 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 42 Years |
Eligibility |
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 |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Reproductive Medicine Associates of New Jersey | Basking Ridge | New Jersey |
Lead Sponsor | Collaborator |
---|---|
Reproductive Medicine Associates of New Jersey |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Impact of monophasic vs. sequential media on the embryos produced from IVF on pregnancy rates | To assess if pregnancy rates are impacted by the type of culture media embryos produced by IVF are cultured in | 2 years | No |
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