InfertilityNCT01939626
Comparison of Human Embryo Development Using Sequential and Single Media With Time-lapse Imaging
A study testing Single-step medium and Standard culture medium in people with Infertility, run by Vitrolife at 4 sites in 2 countries.
Trial summary
The purpose of this study is to compare human embryo in vitro development in sequential and single-step culture medium using time-lapse imaging. Read more about this study
- Who is it for?
- Ages 21 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility
- What is being tested?
- Single-step medium and Standard culture medium
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Sep 2013to Feb 2014
- 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 21 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 6 or more normal embryos following egg retrieval and fertilization.
- Female patients aged 21-40 years or 21-55 years who are using an egg donor.
- Patients using fresh or frozen ejaculated sperm
Who cannot join
- Previous history of cancer
- Day 3 embryo transfer
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States2 sites
Frisco IVF
Frisco, Texas, 75034
Pacific Fertility Center
San Francisco, California, 94133
Sweden2 sites
Fertilitetscentrum
Gothenburg, 40229
Skanes University Hospital
Malmö, 20502
About this study
Official title: Comparison of Human Embryonic Development Using Sequential and Single Media in IVF Monitored by Time-lapse Imaging.
The purpose of this study is to compare human embryo in vitro development in sequential and single-step culture medium using time-lapse imaging.
Read the detailed description
Objective: To study whether a culture medium that allows undisturbed culture supports human embryo development to the blastocyst stage equivalently to a well-established sequential media.
Design: Randomized, double-blinded sibling trial. Setting: Independent in vitro fertilization (IVF) clinics. Patient(s): One hundred twenty-eight patients, with 1,356 zygotes randomized into two study arms.
Intervention(s): Embryos from each patient were randomly allocated into two study arms to compare embryo development on a time-lapse system using a single-step medium or sequential media.
- Conditions
- Infertility
- Being tested
- Single-step medium, Standard culture medium
- Keywords
- embryo, culture
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single-step mediumDevice
Also called Single step culture medium
This medium will allow in vitro culture of human embryos for 5/6 days
Standard culture mediumDevice
This culture system needs media change on day 3 of culture.
| Study group | Role | What they receive |
|---|---|---|
| Single-step medium | Experimental | embryos will be cultured in a single-step medium for 5 days with no change Receives: Device: Single-step medium |
| Control | Other | Embryos cultured in two Culture media for 5 Days. Receives: Device: Standard culture medium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of good quality blastocysts
A cohort of human embryos will be divided into two different media. The ability of the media to support human embryo development will be determined using the standard assessment of the percentage of embryos that achieve a defined embryo grade.
Measured: 5 days of in vitro embryo culture
Secondary outcomes (3)
% GQE DAY 3
Percentage of good quality embryos on day 3 of development
Measured: Measured 3 days after oocyte pick-up
Blast. Utilization rate
Number of blastocyst that are cryopreserved or transfered on either day 5 or 6 of embryo development.
Measured: Measured 5 and 6 days after oocyte pick-up
Blast. rate
Number of embryos reaching the blastocyts stage on either day 5 or day 6.
Measured: Measured 5 and 6 days after oocyte pick-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2013 (estimated)
- Study startSep 2013
- Primary completionFeb 2014
- Study completionFeb 2014
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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study was a two-arm, prospective, randomized, controlled clinical trial performed at four independent IVF clinics. Ovarian stimulation and oocyte collection and fertilization were performed as per each clinic's practice. If \>6 oocytes from the patient were fertilized, the resulting zygotes underwent stratified randomization into the two different media. Allocation was performed in a 1:1 ratio according to a computer-generated randomization list for each couple, which was provided in sealed and numbered envelopes to each clinic. Zygotes randomized into G-1/G-2 underwent a media change from G-1 to G-2 on day 3 and subsequent culture until days 5-6. The zygotes randomized to G-TL were cultured continuously without any media change until days 5-6.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vitrolife
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thorir Hardarson, PhD, Principal investigator, Fertilitetscentrum AB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01939626
- Sponsor's protocol ID
- TL-SCM-2013
- Status last verified
- Jan 2021
- First submitted
- 28 Aug 2013
- Last updated
- 12 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Hardarson T, Bungum M, Conaghan J, Meintjes M, Chantilis SJ, Molnar L, Gunnarsson K, Wikland M. Noninferiority, randomized, controlled trial comparing embryo development using media developed for sequential or undisturbed culture in a time-lapse setup. Fertil Steril. 2015 Dec;104(6):1452-9.e1-4. doi: 10.1016/j.fertnstert.2015.08.037. Epub 2015 Sep 25.
PubMed 26409153
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Human Embryonic Development Using Sequential and Single Media in IVF Monitored by Time-lapse Imaging.
- ClinicalTrials.gov ID
- NCT01939626
- Acronym / sponsor ID
- TL-SCM-2013
- Conditions
- Infertility
- Keywords
- embryo, culture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- VitrolifeIndustry (pharma, biotech, devices)
- Study start
- Sep 2013 (actual)
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 11 Sep 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.
The purpose of this study is to compare human embryo in vitro development in sequential and single-step culture medium using time-lapse imaging.
Detailed description
Objective: To study whether a culture medium that allows undisturbed culture supports human embryo development to the blastocyst stage equivalently to a well-established sequential media.
Design: Randomized, double-blinded sibling trial. Setting: Independent in vitro fertilization (IVF) clinics. Patient(s): One hundred twenty-eight patients, with 1,356 zygotes randomized into two study arms.
Intervention(s): Embryos from each patient were randomly allocated into two study arms to compare embryo development on a time-lapse system using a single-step medium or sequential media.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- This study was a two-arm, prospective, randomized, controlled clinical trial performed at four independent IVF clinics. Ovarian stimulation and oocyte collection and fertilization were performed as per each clinic's practice. If >6 oocytes from the patient were fertilized, the resulting zygotes underwent stratified randomization into the two different media. Allocation was performed in a 1:1 ratio according to a computer-generated randomization list for each couple, which was provided in sealed and numbered envelopes to each clinic. Zygotes randomized into G-1/G-2 underwent a media change from G-1 to G-2 on day 3 and subsequent culture until days 5-6. The zygotes randomized to G-TL were cultured continuously without any media change until days 5-6.
| Arm | Type | Receives |
|---|---|---|
| Single-step medium | Experimental | Device: Single-step mediumembryos will be cultured in a single-step medium for 5 days with no change |
| Control | Other | Device: Standard culture mediumEmbryos cultured in two Culture media for 5 Days. |
Who may qualify
- Ages
- 21 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 6 or more normal embryos following egg retrieval and fertilization.
- Female patients aged 21-40 years or 21-55 years who are using an egg donor.
- Patients using fresh or frozen ejaculated sperm
Key exclusion criteria (2 listed)
- Previous history of cancer
- Day 3 embryo transfer
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 |
|---|---|---|
| Single-step mediumAlso: Single step culture mediumThis medium will allow in vitro culture of human embryos for 5/6 days | Device | Single-step medium |
| Standard culture mediumThis culture system needs media change on day 3 of culture. | Device | Control |
Primary outcome
Percentage of good quality blastocysts
Time frame: 5 days of in vitro embryo culture
A cohort of human embryos will be divided into two different media. The ability of the media to support human embryo development will be determined using the standard assessment of the percentage of embryos that achieve a defined embryo grade.
3 secondary outcomes
% GQE DAY 3
Time frame: Measured 3 days after oocyte pick-up
Blast. Utilization rate
Time frame: Measured 5 and 6 days after oocyte pick-up
Blast. rate
Time frame: Measured 5 and 6 days after oocyte pick-up.
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 12 Jan 2021.
- Derived from this study: PubMed 26409153Hardarson T, Bungum M, Conaghan J, Meintjes M, Chantilis SJ, Molnar L, Gunnarsson K, Wikland M. Noninferiority, randomized, controlled trial comparing embryo development using media developed for sequential or undisturbed culture in a time-lapse setup. Fertil Steril. 2015 Dec;104(6):1452-9.e1-4. doi: 10.1016/j.fertnstert.2015.08.037. Epub 2015 Sep 25.
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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.
Thorir Hardarson, PhD principal investigator
Fertilitetscentrum AB
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single-step medium and Standard culture medium in people with Infertility, run by Vitrolife at 4 sites in 2 countries.
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 3 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: finished, as of the sponsor's last update on 12 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Sweden. 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?
Percentage of good quality blastocysts (time frame: 5 days of in vitro embryo culture). 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 NCT01939626, 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 12 Jan 2021.