InfertilityNXGeMNCT02846012
Comparison of Culture Media for in Vitro Embryo Development
A study testing CSCM2 in people with Infertility, run by Ovation Fertility at 1 site in United States.
Trial summary
The purpose of this study is to collect development and outcome data on human embryos which are cultured in a 2nd generation continuous single culture medium (CSCM2) with the objective to demonstrate its performance efficacy in comparison to existing commercially available single culture or continuous embryo culture… Read more about this study
- Who is it for?
- Ages 18 to 51 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- CSCM2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- May 2016to 22 Dec 2017
- Phase
- Interventional
- 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 51 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- At least 18 years of age in good general physical and mental health.
- Women undergoing fresh in vitro fertilization treatment using their own eggs which will be fertilized by ICSI only
- Normal uterine cavity, as defined by the program.
- Normal BMI (< 35).
- Normal endocrine workup (including PCOS patients).
- Fresh or Frozen Blastocyst transfer
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- At least 4 diploid zygotes showing signs of normal (2PN) fertilisation
- Willing to have half of their 2PN embryos cultured in CSCM and the other half of their 2PN embryos cultured in CSCM 2nd generation
- Willing to comply with study protocol and procedures
- Willing to provide written informed consent
Who cannot join
- Use of donor egg / gestational carrier
- Couples for whom the male partner requires surgically extracted sperm (testicular or epididymal retrieval)
- History of complications related to tolerance to OCP's, Gonadotropins, Progesterone or estrogen.
- A medical condition that is contraindicated to pregnancy or gonadotropin therapy (eg. allergies, immune deficiency, etc.)
- History of cancer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Observational Study Utilizing Next Generation Continuous Single Culture Media (CSCM2) for Comparative in Vitro Embryo Development and Outcome Data
The purpose of this study is to collect development and outcome data on human embryos which are cultured in a 2nd generation continuous single culture medium (CSCM2) with the objective to demonstrate its performance efficacy in comparison to existing commercially available single culture or continuous embryo culture media.
Read the detailed description
A multi-center (3 sites and 2 investigators), prospective trial with up to 300 patients. Patients will be enrolled from participating sites from the United States. Study sites will conduct this study under the oversight of Sterling IRB. Each study site should enroll enough patients to achieve at least 50 evaluable patients that have undergone a treatment cycle using split case sibling embryos in which half of the embryos are cultured in CSCM2 and the other half in current CSCM (as control).
The methods will consist of standard ovarian stimulation protocols at each facility to obtain a sufficient number of mature (MII) oocytes for fertilization by ICSI. Following fertilization, identified diploid (2PN) zygotes will be evenly divided and randomly allocated to the embryo culture treatment conditions of CSCM2 or CSCM and cultured according to standard laboratory procedure (incubated in 5-6% CO2 in air or low O2 concentrations of 5-6%) to the blastocyst stage (Day 5/6 or 7). Top quality blastocyst(s) will be transferred and monitored for implantation, pregnancy and ongoing birth. Embryo transfers will either occur in a fresh or frozen cycle.
The procedures in this study are designed to follow the standard medical care at each study site for women having IVF treatment (the participant will sign a separate consent at your clinic for your IVF procedures). The participants study doctor will explain in detail the procedures participants will undergo at the clinic; this form is only meant to explain the details of the research study. This study does not involve randomization of patient participation or any sham procedures.
- Conditions
- Infertility
- Being tested
- CSCM2
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CSCM2Other
| Study group | Role | What they receive |
|---|---|---|
| CSCM Control | No intervention | Control medium |
| CSCM2 | Experimental | New Formulation medium Receives: Other: CSCM2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pregnancy Success
Live Birth
Measured: 2 years
Secondary outcomes (2)
Implantation
Presence of Gestational Sac
Measured: 2 years
Embryo Development
Blastocyst Utilisation Rate (number of fertilised embryos which develop to usable blastocysts)
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 posted27 Jul 2016 (estimated)
- Study startMay 2016
- Primary completion22 Dec 2017
- Study completion22 Dec 2017
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.
- 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 N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ovation Fertility
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthew VerMilyea, Ovation Fertility
- Investigators
- Matthew VerMilyea, PhD, Principal investigator, Ovation Fertility
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02846012
- Sponsor's protocol ID
- 2016-NxGeM-01
- Acronym
- NXGeM
- Status last verified
- Dec 2017
- First submitted
- 19 Jul 2016
- Last updated
- 27 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Individual participant data will not be shared, however, collated data may be used for publication without patient identification.
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Study Utilizing Next Generation Continuous Single Culture Media (CSCM2) for Comparative in Vitro Embryo Development and Outcome Data
- ClinicalTrials.gov ID
- NCT02846012
- Acronym / sponsor ID
- NXGeM / 2016-NxGeM-01
- Conditions
- Infertility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Ovation FertilityUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- 22 Dec 2017 (actual)
- Study completion
- 22 Dec 2017 (actual)
- First posted
- 27 Jul 2016 (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.
The purpose of this study is to collect development and outcome data on human embryos which are cultured in a 2nd generation continuous single culture medium (CSCM2) with the objective to demonstrate its performance efficacy in comparison to existing commercially available single culture or continuous embryo culture media.
Detailed description
A multi-center (3 sites and 2 investigators), prospective trial with up to 300 patients. Patients will be enrolled from participating sites from the United States. Study sites will conduct this study under the oversight of Sterling IRB. Each study site should enroll enough patients to achieve at least 50 evaluable patients that have undergone a treatment cycle using split case sibling embryos in which half of the embryos are cultured in CSCM2 and the other half in current CSCM (as control).
The methods will consist of standard ovarian stimulation protocols at each facility to obtain a sufficient number of mature (MII) oocytes for fertilization by ICSI. Following fertilization, identified diploid (2PN) zygotes will be evenly divided and randomly allocated to the embryo culture treatment conditions of CSCM2 or CSCM and cultured according to standard laboratory procedure (incubated in 5-6% CO2 in air or low O2 concentrations of 5-6%) to the blastocyst stage (Day 5/6 or 7). Top quality blastocyst(s) will be transferred and monitored for implantation, pregnancy and ongoing birth. Embryo transfers will either occur in a fresh or frozen cycle.
The procedures in this study are designed to follow the standard medical care at each study site for women having IVF treatment (the participant will sign a separate consent at your clinic for your IVF procedures). The participants study doctor will explain in detail the procedures participants will undergo at the clinic; this form is only meant to explain the details of the research study. This study does not involve randomization of patient participation or any sham procedures.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CSCM Control | No intervention | –Control medium |
| CSCM2 | Experimental | Other: CSCM2New Formulation medium |
Who may qualify
- Ages
- 18 to 51 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- At least 18 years of age in good general physical and mental health.
- Women undergoing fresh in vitro fertilization treatment using their own eggs which will be fertilized by ICSI only
- Normal uterine cavity, as defined by the program.
- Normal BMI (< 35).
- Normal endocrine workup (including PCOS patients).
Key exclusion criteria (5 listed)
- Use of donor egg / gestational carrier
- Couples for whom the male partner requires surgically extracted sperm (testicular or epididymal retrieval)
- History of complications related to tolerance to OCP's, Gonadotropins, Progesterone or estrogen.
- A medical condition that is contraindicated to pregnancy or gonadotropin therapy (eg. allergies, immune deficiency, etc.)
- History of cancer
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 |
|---|---|---|
| CSCM2 | Other | CSCM2 |
Primary outcome
Pregnancy Success
Time frame: 2 years
Live Birth
2 secondary outcomes
Implantation
Time frame: 2 years
Embryo Development
Time frame: 2 years
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 27 Dec 2017.
- Individual participant dataSharing planned: No. Individual participant data will not be shared, however, collated data may be used for publication without patient identification.
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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.
Matthew VerMilyea, PhD principal investigator
Ovation Fertility
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CSCM2 in people with Infertility, run by Ovation Fertility 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 10 inclusion and 5 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 27 Dec 2017. 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.
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?
Pregnancy Success (time frame: 2 years). 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 Dec 2017.