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Sequential vs. Monophasic Media Impact Trial (SuMMIT) (SuMMIT)

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ClinicalTrials.gov Identifier: NCT01917240
Recruitment Status : Completed
First Posted : August 6, 2013
Last Update Posted : June 22, 2016
Sponsor:
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment Phase
Infertility Other: Comprehensive Chromosome Screening Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of the Impact of Monophasic vs. Sequential Media on the Reproductive Potential of Embryos Undergoing in Vitro Fertilization (IVF)
Study Start Date : July 2013
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

Arm Intervention/treatment
Experimental: 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 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)
Other: Comprehensive Chromosome Screening
On day 5 or 6 of embryo development, all embryos will undergo a trophectoderm biopsy using the standardized technique, as according to standard laboratory protocol and without regard to study. Comprehensive Chromosome Screening (CCS) results will be available by the morning of day 6 if embryos are suitable for a fresh transfer which is the routine in our program.

Placebo Comparator: Sequential 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 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)
Other: Comprehensive Chromosome Screening
On day 5 or 6 of embryo development, all embryos will undergo a trophectoderm biopsy using the standardized technique, as according to standard laboratory protocol and without regard to study. Comprehensive Chromosome Screening (CCS) results will be available by the morning of day 6 if embryos are suitable for a fresh transfer which is the routine in our program.




Primary Outcome Measures :
  1. Impact of monophasic vs. sequential media on the embryos produced from IVF on pregnancy rates [ Time Frame: 2 years ]
    To assess if pregnancy rates are impacted by the type of culture media embryos produced by IVF are cultured in



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 42 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01917240


Locations
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United States, New Jersey
Reproductive Medicine Associates of New Jersey
Basking Ridge, New Jersey, United States, 07920
Sponsors and Collaborators
Reproductive Medicine Associates of New Jersey
Investigators
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Principal Investigator: Richard T. Scott, M.D., HCLD Reproductive Medicine Associates of New Jersey
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Reproductive Medicine Associates of New Jersey
ClinicalTrials.gov Identifier: NCT01917240    
Other Study ID Numbers: RMA-2013-02
First Posted: August 6, 2013    Key Record Dates
Last Update Posted: June 22, 2016
Last Verified: June 2016
Keywords provided by Reproductive Medicine Associates of New Jersey:
Monophasic
Sequential
Media
Additional relevant MeSH terms:
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Infertility
Genital Diseases, Male
Genital Diseases, Female