Sequential vs. Monophasic Media Impact Trial (SuMMIT)

Reproductive Medicine Associates of New Jersey

Status and phase: Completed; Phase 4

Conditions: Infertility

Treatments: Other: Comprehensive Chromosome Screening

Study type: Interventional

Funder types: Other

Identifiers

NCT01917240

RMA-2013-02

Details and patient eligibility

About

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).

Enrollment: 200 patients

Sex: Female

Ages: 18 to 42 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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200 participants in 2 patient groups, including a placebo group

Monophasic Media

Experimental group

Description:

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)

Treatment:

Other: Comprehensive Chromosome Screening

Sequential Media

Placebo Comparator group

Description:

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)

Treatment:

Other: Comprehensive Chromosome Screening