InfertilityNCT02302638
Embryo Development Using Two Commercial Single-step Media
A study testing embryo culture in different single-step media in people with Infertility, run by Eugonia at 1 site in Greece.
Trial summary
This prospective study with sibling oocytes will evaluate the efficiency of two commercial single-step media, namely Sage 1-step and Continuous Single Culture Medium (CSCM), in terms of embryo utilization rates, blastocyst formation rates, embryo quality and pregnancy rates. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility
- What is being tested?
- embryo culture in different single-step media
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteGreece
- Study dates
- Nov 2014to Jun 2015
- 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- at least 10 oocytes retrieved
Who cannot join
- frozen oocytes
- testicular biopsy
- less than 10 oocytes retrieved
- older than 40 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Embryo Development and Utilization Using Two Commercial Single-step Media
This prospective study with sibling oocytes will evaluate the efficiency of two commercial single-step media, namely Sage 1-step and Continuous Single Culture Medium (CSCM), in terms of embryo utilization rates, blastocyst formation rates, embryo quality and pregnancy rates. Embryos will be cultured continuously for up to 6 days under identical conditions.
- Conditions
- Infertility
- Being tested
- embryo culture in different single-step media
- Keywords
- single-step media, embryo development, blastocyst formation, embryo utilization
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
embryo culture in different single-step mediaOther
Half of each patient's oocytes will be randomly allocated to be cultured either in Sage 1-step medium (Origio) or in CSC medium (Irvine Scientific) for up to six days following oocyte retrieval.
| Study group | Role | What they receive |
|---|---|---|
| Sage 1-step | Active comparator | Embryo culture in different single-step media:
Half of each patient's oocytes will be randomly allocated to be cultured in Sage 1-step medium for up to six days following oocyte retrieval. Receives: Other: embryo culture in different single-step media |
| CSCM | Active comparator | Embryo culture in different single-step media:
Half of each patient's oocytes will be randomly allocated to be cultured in CSC medium for up to six days following oocyte retrieval. Receives: Other: embryo culture in different single-step media |
What is being measured
The primary outcome is the main question the study is designed to answer.
Utilization rates
Utilization = embryos selected for transfer and cryopreservation
Measured: 6 days post oocyte retrieval
Blastocyst formation
Number of blastocysts on day 5 post oocyte retrieval per fertilized oocytes
Measured: 5 days post oocyte retrieval
Secondary outcomes (4)
Embryo quality on day 3
Measured: 3 days post oocyte retrieval
blastocyst quality on day 5
Measured: 5 days post oocyte retrieval
positive pregnancy test
Measured: 15 days post oocyte retrieval
clinical pregnancy
presence of gestational sac with positive fetal heartbeat
Measured: 7 weeks of gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2014 (estimated)
- Study startNov 2014
- Primary completionJun 2015
- Study completionJun 2015
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eugonia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ioannis A Sfontouris, PhD, Principal investigator, Eugonia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02302638
- Sponsor's protocol ID
- Sage vs CSCM
- Status last verified
- Jun 2015
- First submitted
- 25 Nov 2014
- Last updated
- 9 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Sfontouris IA, Kolibianakis EM, Lainas GT, Venetis CA, Petsas GK, Tarlatzis BC, Lainas TG. Blastocyst utilization rates after continuous culture in two commercial single-step media: a prospective randomized study with sibling oocytes. J Assist Reprod Genet. 2017 Oct;34(10):1377-1383. doi: 10.1007/s10815-017-0997-0. Epub 2017 Jul 17.
PubMed 28718081
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Embryo Development and Utilization Using Two Commercial Single-step Media
- ClinicalTrials.gov ID
- NCT02302638
- Acronym / sponsor ID
- Sage vs CSCM
- Conditions
- Infertility
- Keywords
- single-step media, embryo development, blastocyst formation, embryo utilization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- EugoniaUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 27 Nov 2014 (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.
This prospective study with sibling oocytes will evaluate the efficiency of two commercial single-step media, namely Sage 1-step and Continuous Single Culture Medium (CSCM), in terms of embryo utilization rates, blastocyst formation rates, embryo quality and pregnancy rates. Embryos will be cultured continuously for up to 6 days under identical conditions.
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 |
|---|---|---|
| Sage 1-step | Active comparator | Other: embryo culture in different single-step mediaEmbryo culture in different single-step media: Half of each patient's oocytes will be randomly allocated to be cultured in Sage 1-step medium for up to six days following oocyte retrieval. |
| CSCM | Active comparator | Other: embryo culture in different single-step mediaEmbryo culture in different single-step media: Half of each patient's oocytes will be randomly allocated to be cultured in CSC medium for up to six days following oocyte retrieval. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- at least 10 oocytes retrieved
Key exclusion criteria (4 listed)
- frozen oocytes
- testicular biopsy
- less than 10 oocytes retrieved
- older than 40 years
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 in different single-step mediaHalf of each patient's oocytes will be randomly allocated to be cultured either in Sage 1-step medium (Origio) or in CSC medium (Irvine Scientific) for up to six days following oocyte retrieval. | Other | CSCM, Sage 1-step |
Primary outcome
Utilization rates
Time frame: 6 days post oocyte retrieval
Utilization = embryos selected for transfer and cryopreservation
Blastocyst formation
Time frame: 5 days post oocyte retrieval
Number of blastocysts on day 5 post oocyte retrieval per fertilized oocytes
4 secondary outcomes
Embryo quality on day 3
Time frame: 3 days post oocyte retrieval
blastocyst quality on day 5
Time frame: 5 days post oocyte retrieval
positive pregnancy test
Time frame: 15 days post oocyte retrieval
clinical pregnancy
Time frame: 7 weeks of gestation
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 9 Jun 2015.
- Derived from this study: PubMed 28718081Sfontouris IA, Kolibianakis EM, Lainas GT, Venetis CA, Petsas GK, Tarlatzis BC, Lainas TG. Blastocyst utilization rates after continuous culture in two commercial single-step media: a prospective randomized study with sibling oocytes. J Assist Reprod Genet. 2017 Oct;34(10):1377-1383. doi: 10.1007/s10815-017-0997-0. Epub 2017 Jul 17.
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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.
Ioannis A Sfontouris, PhD principal investigator
Eugonia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing embryo culture in different single-step media in people with Infertility, run by Eugonia at 1 site in Greece.
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 1 inclusion and 4 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 9 Jun 2015. 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 Greece. 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?
Utilization rates (time frame: 6 days post oocyte retrieval). The study lists 2 primary outcomes in all. 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 NCT02302638, 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 9 Jun 2015.