InfertilityPhase 4SuMMITNCT01917240
Sequential vs. Monophasic Media Impact Trial (SuMMIT)
A Phase 4 study testing Comprehensive Chromosome Screening in people with Infertility, run by Reproductive Medicine Associates of New Jersey at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 42 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Comprehensive Chromosome Screening
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to May 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 42 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Reproductive Medicine Associates of New Jersey
Basking Ridge, New Jersey, 07920
About this study
Official 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).
- Conditions
- Infertility
- Being tested
- Comprehensive Chromosome Screening
- Keywords
- Monophasic, Sequential, Media
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comprehensive Chromosome ScreeningOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Monophasic Media | Experimental | 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) Receives: Other: Comprehensive Chromosome Screening |
| Sequential Media | Placebo comparator | 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) Receives: Other: Comprehensive Chromosome Screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2013 (estimated)
- Study startJul 2013
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Reproductive Medicine Associates of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richard T. Scott, M.D., HCLD, Principal investigator, Reproductive Medicine Associates of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01917240
- Sponsor's protocol ID
- RMA-2013-02
- Acronym
- SuMMIT
- Status last verified
- Jun 2016
- First submitted
- 18 Jul 2013
- Last updated
- 22 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26826274
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Impact of Monophasic vs. Sequential Media on the Reproductive Potential of Embryos Undergoing in Vitro Fertilization (IVF)
- ClinicalTrials.gov ID
- NCT01917240
- Acronym / sponsor ID
- SuMMIT / RMA-2013-02
- Conditions
- Infertility
- Keywords
- Monophasic, Sequential, Media
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Reproductive Medicine Associates of New JerseyUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 6 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Monophasic Media | Experimental | Other: Comprehensive Chromosome ScreeningHalf 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) |
| Sequential Media | Placebo comparator | Other: Comprehensive Chromosome ScreeningHalf 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) |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Patient undergoing IVF/CCS (no PGD banking)
- Patient meets ASRM guidelines for Double Embryo Transfer (DET)
- Donor Sperm OK
- AMH ≥ 1.2
- FSH ≤ 12
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Comprehensive Chromosome ScreeningOn 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. | Other | Monophasic Media, Sequential Media |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2016.
- Derived from this study: PubMed 26826274Werner 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.
Related trials for Infertility
RecruitingPhase 3
A Study to Compare the Efficacy and Safety of Follitropin Alfa/Lutropin Alfa Versus hMG in Japanese Participants With LH and FSH Deficiency Undergoing ART (HINATA)
Infertility
Active, not recruitingObservational study
Fresh Versus Vitrified-Warmed Donor Oocytes: Embryological and Clinical Outcomes
Infertility, Donor Oocyte Assisted Reproduction
RecruitingObservational study
Safety and Efficacy of Corifollitropin Alfa N02 Injection in Elderly Women Undergoing Assisted Reproductive Technology (ART)
Infertility
Active, not recruiting
Automation of the In Vitro Fertilization Laboratory
Infertility, ART
Not yet recruiting
Implementing IVM for Fertility Treatment in Clinical Practice
Infertility
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard T. Scott, M.D., HCLD principal investigator
Reproductive Medicine Associates of New Jersey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Comprehensive Chromosome Screening in people with Infertility, run by Reproductive Medicine Associates of New Jersey at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact of monophasic vs. sequential media on the embryos produced from IVF on pregnancy rates (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01917240, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2016.