InfertilityPhase 4NCT03687697
Comparison of Global, G-TL, & Cornell Media
A Phase 4 study testing Global vs. G-TL vs Cornell's C3 vs Cornell's C1/C2 media in people with Infertility, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
This is a prospective, randomized clinical trial to compare the Global commercial single step media to 1) G-TL (Vitrolife), 2) Weill Cornell's single step and sequential steps media, which all support human embryo development in the laboratory using the Vitrolife Time-Lapse system. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Infertility
- What is being tested?
- Global vs. G-TL vs Cornell's C3 vs Cornell's C1/C2 media
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2018to 1 May 2018
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 40 years of age or younger (maternal)
- 65 years of age or younger (paternal)
- 10 or more oocytes
- Fresh or frozen oocytes (including donor)
- Fresh or frozen (including donor) sperm can be used
- ICSI only
- Frozen embryos from this study can be included in the outcome portion of this study.
- PGD and/or PGS patients included
Who cannot join
- Patients with less than 10 oocytes
- Co-culture patients
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Reproductive Medicine
New York, New York, 10065
About this study
Official title: A Randomized Controlled Trial Comparing Global Medium With G-TL, Cornell Single and Sequential Steps Media by the Time-Lapse System.
This is a prospective, randomized clinical trial to compare the Global commercial single step media to 1) G-TL (Vitrolife), 2) Weill Cornell's single step and sequential steps media, which all support human embryo development in the laboratory using the Vitrolife Time-Lapse system. The main goal of the study is to identify the best culture medium for optimal embryo development.
Read the detailed description
Culture media are used to culture embryos in order to support their development in the laboratory. New media are being introduced to the market. Clinical studies have shown that the use of the single-step Global medium for culture of human embryos from the zygote stage to the blastocyst stage has resulted in better in-vitro development than a variety of sequential media system.
Global is a FDA approved commercial single-step medium for all embryo culture from Day 0 to the blastocyst stage.
G-TL (Time-Lapse) is a FDA approved commercial single-step medium from Vitrolife. It was developed to be used with time-lapse devices as a continuous embryo culture medium from Day 0 to Day 5/6.
C3 is Cornell's in house made single-step buffered medium for embryo culture from oocyte fertilization to blastocyst stage used as standard of care.
C1/C2 is Cornell's in house made buffered sequential medium otherwise known as multi step medium, use to culture embryos for development. It is formulated to meet the embryos requirements at two specific stages of development but require removal of the dish from the incubator to physically exchange the culture media surrounding the embryos. This medium will be the control.
- Conditions
- Infertility
- Being tested
- Global vs. G-TL vs Cornell's C3 vs Cornell's C1/C2 media
- Keywords
- IVF
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Global vs. G-TL vs Cornell's C3 vs Cornell's C1/C2 mediaBiological
A comparison between Global, G-TL, Cornell's C3, and Cornell's C1/C2 embryo culture media.
| Study group | Role | What they receive |
|---|---|---|
| Global vs. G-TL Media | Experimental | Global medium will be compared with G-TL (Time-Lapse) medium. Receives: Biological: Global vs. G-TL vs Cornell's C3 vs Cornell's C1/C2 media |
| Global vs. Cornell's C3 Media | Experimental | Global medium will be compared with Cornell's C3 single step medium. Receives: Biological: Global vs. G-TL vs Cornell's C3 vs Cornell's C1/C2 media |
| Global vs. Cornell's sequential Media | Experimental | Global medium will be compared with Cornell's C1/C2 sequential medium. Receives: Biological: Global vs. G-TL vs Cornell's C3 vs Cornell's C1/C2 media |
What is being measured
The primary outcome is the main question the study is designed to answer.
Embryo development
Comparison of embryo development using standard assessments of morphology, cell number, and embryo grading, between the different media groups.
Measured: Day 5
Secondary outcomes (2)
Implantation rate
The ratio of embryo implantation measured through ultrasound
Measured: 4 weeks
Pregnancy rate
The ratio of pregnancy measured through βHCG
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2018
- Study start1 Apr 2018
- Primary completion1 May 2018
- Study completion1 May 2018
Why it stopped: The study was halted prior to enrollment of first participant due to non funding and recourses.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nikica Zaninovic, PhD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03687697
- Sponsor's protocol ID
- 1707018347
- Status last verified
- Sep 2018
- First submitted
- 31 Jul 2018
- Last updated
- 27 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Comparing Global Medium With G-TL, Cornell Single and Sequential Steps Media by the Time-Lapse System.
- ClinicalTrials.gov ID
- NCT03687697
- Acronym / sponsor ID
- 1707018347
- Conditions
- Infertility
- Keywords
- IVF
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study was halted prior to enrollment of first participant due to non funding and recourses.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 1 May 2018 (actual)
- Study completion
- 1 May 2018 (actual)
- First posted
- 27 Sep 2018 (actual)
- 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.
This is a prospective, randomized clinical trial to compare the Global commercial single step media to 1) G-TL (Vitrolife), 2) Weill Cornell's single step and sequential steps media, which all support human embryo development in the laboratory using the Vitrolife Time-Lapse system. The main goal of the study is to identify the best culture medium for optimal embryo development.
Detailed description
Culture media are used to culture embryos in order to support their development in the laboratory. New media are being introduced to the market. Clinical studies have shown that the use of the single-step Global medium for culture of human embryos from the zygote stage to the blastocyst stage has resulted in better in-vitro development than a variety of sequential media system.
Global is a FDA approved commercial single-step medium for all embryo culture from Day 0 to the blastocyst stage.
G-TL (Time-Lapse) is a FDA approved commercial single-step medium from Vitrolife. It was developed to be used with time-lapse devices as a continuous embryo culture medium from Day 0 to Day 5/6.
C3 is Cornell's in house made single-step buffered medium for embryo culture from oocyte fertilization to blastocyst stage used as standard of care.
C1/C2 is Cornell's in house made buffered sequential medium otherwise known as multi step medium, use to culture embryos for development. It is formulated to meet the embryos requirements at two specific stages of development but require removal of the dish from the incubator to physically exchange the culture media surrounding the embryos. This medium will be the control.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Global vs. G-TL Media | Experimental | Biological: Global vs. G-TL vs Cornell's C3 vs Cornell's C1/C2 mediaGlobal medium will be compared with G-TL (Time-Lapse) medium. |
| Global vs. Cornell's C3 Media | Experimental | Biological: Global vs. G-TL vs Cornell's C3 vs Cornell's C1/C2 mediaGlobal medium will be compared with Cornell's C3 single step medium. |
| Global vs. Cornell's sequential Media | Experimental | Biological: Global vs. G-TL vs Cornell's C3 vs Cornell's C1/C2 mediaGlobal medium will be compared with Cornell's C1/C2 sequential medium. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 40 years of age or younger (maternal)
- 65 years of age or younger (paternal)
- 10 or more oocytes
- Fresh or frozen oocytes (including donor)
- Fresh or frozen (including donor) sperm can be used
Key exclusion criteria (2 listed)
- Patients with less than 10 oocytes
- Co-culture patients
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 |
|---|---|---|
| Global vs. G-TL vs Cornell's C3 vs Cornell's C1/C2 mediaA comparison between Global, G-TL, Cornell's C3, and Cornell's C1/C2 embryo culture media. | Biological | Global vs. Cornell's C3 Media, Global vs. Cornell's sequential Media, Global vs. G-TL Media |
Primary outcome
Embryo development
Time frame: Day 5
Comparison of embryo development using standard assessments of morphology, cell number, and embryo grading, between the different media groups.
2 secondary outcomes
Implantation rate
Time frame: 4 weeks
Pregnancy rate
Time frame: 6 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2018.
- Individual participant dataSharing planned: No
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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.
Nikica Zaninovic, PhD principal investigator
Weill Medical College of Cornell University
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 Global vs. G-TL vs Cornell's C3 vs Cornell's C1/C2 media in people with Infertility, run by Weill Medical College of Cornell University 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 2 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: withdrawn, as of the sponsor's last update on 27 Sep 2018. 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. 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 was withdrawn before enrolling participants, so there are no results.
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?
Embryo development (time frame: Day 5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Sep 2018.