InfertilityEmbryoSureNCT01587547
Amino Acid Profiling of Spent Culture Medium
An observational study of Infertility, run by Origio A/S at 2 sites in United Kingdom.
Trial summary
The purpose of this study is to develop an algorithm for embryo selection based on amino acid profiling (AAP) of spent culture medium. Development of the algorithm will be based on the ongoing implantation rate of the individual embryos transferred. As evaluated by ultrasound scan in gestational week 7. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Infertility
- How many people
- 10 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Apr 2012to Apr 2013
- Phase
- Observational
- 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
- No healthy volunteers
- Adult
Study population: Subjects will be recruited from couples and single women attending the IVF clinic for IVF/ICSI treatment.
Who may be able to join
- Minimum 4 x 2PN´s on Day 1 post insemination
- Subjects undergoing IVF or ICSI treatment with a maximum of 2 embryos transferred
- Both partners should be capable of understanding the study to which they are consenting
- Females > 18 and ≤ 40 years of age
- Regular menstrual cycle 21-35 days (both inclusive)
- Women treated with a standard drug protocol
Who cannot join
- The couple has previously participated in the DK005 study
- Use of assisted hatching
- Indication for TESA or PESA
- Any medical conditions or genetic disorders prohibiting IVF/ICSI or interfering with the interpretation of results of the study (including pre- implantation genetic diagnostics).
- Use of any investigational drug within 30 days before oocyte retrieval
- Any severe chronic disease of relevance for reproductive function.
- Oocyte donation patients (donor or recipient).
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
The Hewitt Centre for Reproductive Medicine, Liverpool Women's Hospital
Liverpool, L8 7SS
Hammersmith IVF, Hammersmith Hospital
London, W12 0HS
About this study
Official title: Amino Acid Profiling of Spent Culture Medium to Retrospectively Determine Individual Embryo Selection Criteria for Improved Clinical IVF Outcome
The purpose of this study is to develop an algorithm for embryo selection based on amino acid profiling (AAP) of spent culture medium. Development of the algorithm will be based on the ongoing implantation rate of the individual embryos transferred. As evaluated by ultrasound scan in gestational week 7.
Read the detailed description
IVF/ICSI treatment has permitted many thousands of couples to conceive worldwide yet is limited by low success rates (in UK, approx. 25% live birth rate/treatment cycle for women up to 42 years of age; HFEA Annual Report, 2006) and a confounding high multiple birth rate (23%) due to the transfer of more than a single pre-implantation embryo. Multiple births are associated with prematurity, increased neonatal and maternal mortality and child handicap as well as being a major burden for health care systems. These problems have been highlighted in the data published by the HFEA (2009), which has called for "a professionally-led, coordinated national strategy to reduce the number of multiple births". This challenge could be met if single embryos of known developmental competence could be selected for transfer, thereby making the embryo selection process even more crucial. However, current non-invasive embryo selection criteria using light microscope analysis have limited predictive value for ongoing pregnancy.
- Conditions
- Infertility
- Keywords
- ART, IVF, ICSI, embryo selection
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| IVF and ICSI patients | Subjects undergoing IVF or ICSI treatment with a maximum of 2 embryos transferred |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amino acid profile
Amino acid profiling (AAP) will be performed of spent culture medium from individually cultured embryos. AAP results will be correlated to the ongoing implantation rate week 7 as well as morphological embryo development parametres.
Measured: After 24 hours of culture
Secondary outcomes (1)
Ongoing clinical pregnancy rate
Evaluated by ultrasound scan
Measured: Gestational week 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2012 (estimated)
- Study startApr 2012
- Primary completionDec 2012
- Study completionApr 2013
Why it stopped: ORIGIO a/s acquired by Cooper Surgical Inc. who decided to withdraw from the project
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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Origio A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Novocellus Ltd., Signifikans ApS
- Responsible party
- Sponsor
- Investigators
- Helen M Picton, BSc, PhD, Principal investigator, Leeds Institute of Genetic Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01587547
- Sponsor's protocol ID
- DK005
- Other IDs
- CI/2010/0041
- Acronym
- EmbryoSure
- Status last verified
- May 2013
- First submitted
- 26 Apr 2012
- Last updated
- 8 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Amino Acid Profiling of Spent Culture Medium to Retrospectively Determine Individual Embryo Selection Criteria for Improved Clinical IVF Outcome
- ClinicalTrials.gov ID
- NCT01587547
- Acronym / sponsor ID
- EmbryoSure / DK005
- Conditions
- Infertility
- Keywords
- ART, IVF, ICSI, embryo selection
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: ORIGIO a/s acquired by Cooper Surgical Inc. who decided to withdraw from the project
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Origio A/SIndustry (pharma, biotech, devices)
- Collaborators
- Novocellus Ltd., Signifikans ApS
- Study start
- Apr 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 30 Apr 2012 (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 develop an algorithm for embryo selection based on amino acid profiling (AAP) of spent culture medium. Development of the algorithm will be based on the ongoing implantation rate of the individual embryos transferred. As evaluated by ultrasound scan in gestational week 7.
Detailed description
IVF/ICSI treatment has permitted many thousands of couples to conceive worldwide yet is limited by low success rates (in UK, approx. 25% live birth rate/treatment cycle for women up to 42 years of age; HFEA Annual Report, 2006) and a confounding high multiple birth rate (23%) due to the transfer of more than a single pre-implantation embryo. Multiple births are associated with prematurity, increased neonatal and maternal mortality and child handicap as well as being a major burden for health care systems. These problems have been highlighted in the data published by the HFEA (2009), which has called for "a professionally-led, coordinated national strategy to reduce the number of multiple births". This challenge could be met if single embryos of known developmental competence could be selected for transfer, thereby making the embryo selection process even more crucial. However, current non-invasive embryo selection criteria using light microscope analysis have limited predictive value for ongoing pregnancy.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IVF and ICSI patients | – | –Subjects undergoing IVF or ICSI treatment with a maximum of 2 embryos transferred |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Subjects will be recruited from couples and single women attending the IVF clinic for IVF/ICSI treatment.
Key inclusion criteria (6 listed)
- Minimum 4 x 2PN´s on Day 1 post insemination
- Subjects undergoing IVF or ICSI treatment with a maximum of 2 embryos transferred
- Both partners should be capable of understanding the study to which they are consenting
- Females > 18 and ≤ 40 years of age
- Regular menstrual cycle 21-35 days (both inclusive)
Key exclusion criteria (7 listed)
- The couple has previously participated in the DK005 study
- Use of assisted hatching
- Indication for TESA or PESA
- Any medical conditions or genetic disorders prohibiting IVF/ICSI or interfering with the interpretation of results of the study (including pre- implantation genetic diagnostics).
- Use of any investigational drug within 30 days before oocyte retrieval
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Amino acid profile
Time frame: After 24 hours of culture
Amino acid profiling (AAP) will be performed of spent culture medium from individually cultured embryos. AAP results will be correlated to the ongoing implantation rate week 7 as well as morphological embryo development parametres.
1 secondary outcome
Ongoing clinical pregnancy rate
Time frame: Gestational week 7
Results and safety
The study was stopped early (reason given: ORIGIO a/s acquired by Cooper Surgical Inc. who decided to withdraw from the project). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2013.
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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.
Helen M Picton, BSc, PhD principal investigator
Leeds Institute of Genetic Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility, run by Origio A/S at 2 sites in United Kingdom.
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 6 inclusion and 7 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: stopped early, as of the sponsor's last update on 8 May 2013. 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 Kingdom. 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 was stopped early (reason given: ORIGIO a/s acquired by Cooper Surgical Inc. who decided to withdraw from the project). Results are not available in the source record.
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?
Amino acid profile (time frame: After 24 hours of culture). 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 8 May 2013.