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

Primary Purpose

Infertility

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Comprehensive Chromosome Screening
Sponsored by
Reproductive Medicine Associates of New Jersey
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility focused on measuring Monophasic, Sequential, Media

Eligibility Criteria

18 Years - 42 Years (Adult)FemaleDoes not accept 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

Sites / Locations

  • Reproductive Medicine Associates of New Jersey

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Monophasic Media

Sequential Media

Arm 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)

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)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
July 18, 2013
Last Updated
June 21, 2016
Sponsor
Reproductive Medicine Associates of New Jersey
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1. Study Identification

Unique Protocol Identification Number
NCT01917240
Brief Title
Sequential vs. Monophasic Media Impact Trial (SuMMIT)
Acronym
SuMMIT
Official Title
Evaluation of the Impact of Monophasic vs. Sequential Media on the Reproductive Potential of Embryos Undergoing in Vitro Fertilization (IVF)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Reproductive Medicine Associates of New Jersey

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
Monophasic, Sequential, Media

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Monophasic Media
Arm Type
Experimental
Arm 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)
Arm Title
Sequential Media
Arm Type
Placebo Comparator
Arm 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)
Intervention Type
Other
Intervention Name(s)
Comprehensive Chromosome Screening
Intervention Description
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 Measure Information:
Title
Impact of monophasic vs. sequential media on the embryos produced from IVF on pregnancy rates
Description
To assess if pregnancy rates are impacted by the type of culture media embryos produced by IVF are cultured in
Time Frame
2 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
42 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard T. Scott, M.D., HCLD
Organizational Affiliation
Reproductive Medicine Associates of New Jersey
Official's Role
Principal Investigator
Facility Information:
Facility Name
Reproductive Medicine Associates of New Jersey
City
Basking Ridge
State/Province
New Jersey
ZIP/Postal Code
07920
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
26826274
Citation
Werner MD, Hong KH, Franasiak JM, Forman EJ, Reda CV, Molinaro TA, Upham KM, Scott RT Jr. Sequential versus Monophasic Media Impact Trial (SuMMIT): a paired randomized controlled trial comparing a sequential media system to a monophasic medium. Fertil Steril. 2016 May;105(5):1215-1221. doi: 10.1016/j.fertnstert.2016.01.005. Epub 2016 Jan 27.
Results Reference
derived
Links:
URL
http://www.rmanj.com/
Description
Reproductive Medicine Associates of New Jersey

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Sequential vs. Monophasic Media Impact Trial (SuMMIT)

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