- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01917240
Sequential vs. Monophasic Media Impact Trial (SuMMIT) (SuMMIT)
June 21, 2016 updated by: Reproductive Medicine Associates of New Jersey
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
200
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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New Jersey
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Basking Ridge, New Jersey, United States, 07920
- Reproductive Medicine Associates of New Jersey
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 42 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / 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)
|
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)
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Richard T. Scott, M.D., HCLD, Reproductive Medicine Associates of New Jersey
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2013
Primary Completion (Actual)
May 1, 2016
Study Completion (Actual)
May 1, 2016
Study Registration Dates
First Submitted
July 18, 2013
First Submitted That Met QC Criteria
August 2, 2013
First Posted (Estimate)
August 6, 2013
Study Record Updates
Last Update Posted (Estimate)
June 22, 2016
Last Update Submitted That Met QC Criteria
June 21, 2016
Last Verified
June 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RMA-2013-02
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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