InfertilityNCT02457481
An Alternative Culture Medium to Better Support Preimplantation Embryo Development in Vitro
A study testing Embryo Culture medium in people with Infertility and Reproductive Techniques, Assisted, run by National Foundation for Fertility Research at 2 sites in United States.
Trial summary
The purpose of this research study is to evaluate a newly developed embryo culture media system for human clinical use in ART. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Infertility, Reproductive Techniques, Assisted
- What is being tested?
- Embryo Culture medium
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2015to Aug 2018
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult women of any age who come to Colorado Center for Reproductive Medicine for fertility treatment using IVF.
- Patients can be of any race, culture, sexual orientation or ethnicity.
Who cannot join
- Minors are excluded from the study
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Fertility Laboratories of Colorado
Lone Tree, Colorado, 80124
National Fooundation for Fertility Research
Lone Tree, Colorado, 80124
About this study
The purpose of this research study is to evaluate a newly developed embryo culture media system for human clinical use in ART.
Read the detailed description
Egg retrieval will be performed as per standard operating procedures. Eggs from a single patient are mixed together in a single group during the normal recovery and washing procedure following egg retrieval. The single group of eggs will be divided in half, then the embryologist will randomly place each half into one of the two culture media treatments, commercial or experimental. All mature eggs collected at retrieval will undergo fertilization per standard operating procedures according to physician recommendations. After fertilization (day 0), standard procedures involve in vitro embryo culture in a sequential two step media system. After confirmation of fertilization success on day 1, embryos are cultured until day 3 in step 1 medium (both commercial and experimental media are two step sequential culture systems). On day 3, embryos are evaluated and moved from step one to step two culture medium. On day 5 and day 6, embryo development will be assessed. Good quality blastocysts will either be transferred fresh or cryopreserved for later transfer and/or genetic testing.
- Conditions
- Infertility, Reproductive Techniques, Assisted
- Being tested
- Embryo Culture medium
- Keywords
- Embryo Culture Techniques, Embryonic Development
- Medical subject headings
- Infertility, Helping Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Embryo Culture mediumDevice
Two step sequential embryo culture medium system
| Study group | Role | What they receive |
|---|---|---|
| Embryo Culture medium | Experimental | Embryos from each patient are randomly allocated to culture in the commercial or experimental embryo culture medium (half of the embryos in commercial and half in experimental medium). Receives: Device: Embryo Culture medium |
What is being measured
The primary outcome is the main question the study is designed to answer.
embryo development
Blastocyst development and quality on days 5 and 6 of culture
Measured: 7 days after egg retrieval
pregnancy rate
The incidence of implantation and pregnancy following embryo transfer, including initial pregnancy test and ultrasound examination.
Measured: 2 months after egg retrieval
offspring weight
The birth weight of children born
Measured: 1 year after egg retrieval
offspring gender
The gender of children born
Measured: 1 year after egg retrieval
Secondary outcomes (2)
fertilization
the percentage of mature eggs that successfully fertilized normally
Measured: 2 days after egg retrieval
euploid embryos
For patients undergoing comprehensive chromosome screening, percent normal euploid blastocysts
Measured: 1 month after egg retrieval
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2015 (estimated)
- Study startMay 2015
- Primary completionAug 2018
- Study completionAug 2018
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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Foundation for Fertility Research
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rebecca L Krisher, PhD, Principal investigator, NFFR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02457481
- Sponsor's protocol ID
- NFFR-OEC-2015
- Status last verified
- Aug 2018
- First submitted
- 13 May 2015
- Last updated
- 28 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Alternative Culture Medium to Better Support Preimplantation Embryo Development in Vitro
- ClinicalTrials.gov ID
- NCT02457481
- Acronym / sponsor ID
- NFFR-OEC-2015
- Conditions
- Infertility, Reproductive Techniques, Assisted
- Keywords
- Embryo Culture Techniques, Embryonic Development
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- National Foundation for Fertility ResearchUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Aug 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 29 May 2015 (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 research study is to evaluate a newly developed embryo culture media system for human clinical use in ART.
Detailed description
Egg retrieval will be performed as per standard operating procedures. Eggs from a single patient are mixed together in a single group during the normal recovery and washing procedure following egg retrieval. The single group of eggs will be divided in half, then the embryologist will randomly place each half into one of the two culture media treatments, commercial or experimental. All mature eggs collected at retrieval will undergo fertilization per standard operating procedures according to physician recommendations. After fertilization (day 0), standard procedures involve in vitro embryo culture in a sequential two step media system. After confirmation of fertilization success on day 1, embryos are cultured until day 3 in step 1 medium (both commercial and experimental media are two step sequential culture systems). On day 3, embryos are evaluated and moved from step one to step two culture medium. On day 5 and day 6, embryo development will be assessed. Good quality blastocysts will either be transferred fresh or cryopreserved for later transfer and/or genetic testing.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Embryo Culture medium | Experimental | Device: Embryo Culture mediumEmbryos from each patient are randomly allocated to culture in the commercial or experimental embryo culture medium (half of the embryos in commercial and half in experimental medium). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult women of any age who come to Colorado Center for Reproductive Medicine for fertility treatment using IVF.
- Patients can be of any race, culture, sexual orientation or ethnicity.
Key exclusion criteria (1 listed)
- Minors are excluded from the study
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 |
|---|---|---|
| Embryo Culture mediumTwo step sequential embryo culture medium system | Device | Embryo Culture medium |
Primary outcome
embryo development
Time frame: 7 days after egg retrieval
Blastocyst development and quality on days 5 and 6 of culture
pregnancy rate
Time frame: 2 months after egg retrieval
The incidence of implantation and pregnancy following embryo transfer, including initial pregnancy test and ultrasound examination.
offspring weight
Time frame: 1 year after egg retrieval
The birth weight of children born
offspring gender
Time frame: 1 year after egg retrieval
The gender of children born
2 secondary outcomes
fertilization
Time frame: 2 days after egg retrieval
euploid embryos
Time frame: 1 month after egg retrieval
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 28 Aug 2018.
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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.
Rebecca L Krisher, PhD principal investigator
NFFR
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Embryo Culture medium in people with Infertility and Reproductive Techniques, Assisted, run by National Foundation for Fertility Research at 2 sites 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 2 inclusion and 1 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 28 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
embryo development (time frame: 7 days after egg retrieval). The study lists 4 primary outcomes in all. 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 28 Aug 2018.