Study Stopped
ORIGIO a/s acquired by Cooper Surgical Inc. who decided to withdraw from the project
Amino Acid Profiling of Spent Culture Medium
EmbryoSure
2 other identifiers
observational
10
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Apr 2012
Shorter than P25 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2012
CompletedFirst Submitted
Initial submission to the registry
April 26, 2012
CompletedFirst Posted
Study publicly available on registry
April 30, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2013
CompletedMay 8, 2013
May 1, 2013
8 months
April 26, 2012
May 7, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
After 24 hours of culture
Secondary Outcomes (1)
Ongoing clinical pregnancy rate
Gestational week 7
Study Arms (1)
IVF and ICSI patients
Subjects undergoing IVF or ICSI treatment with a maximum of 2 embryos transferred
Eligibility Criteria
Subjects will be recruited from couples and single women attending the IVF clinic for IVF/ICSI treatment.
You may qualify if:
- 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
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Origio A/Slead
- Novocellus Ltd.collaborator
- Signifikans ApScollaborator
Study Sites (2)
The Hewitt Centre for Reproductive Medicine, Liverpool Women's Hospital
Liverpool, L8 7SS, United Kingdom
Hammersmith IVF, Hammersmith Hospital
London, W12 0HS, United Kingdom
Biospecimen
Spent culture medium from the individual embryos
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Helen M Picton, BSc, PhD
Leeds Institute of Genetic Health
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 26, 2012
First Posted
April 30, 2012
Study Start
April 1, 2012
Primary Completion
December 1, 2012
Study Completion
April 1, 2013
Last Updated
May 8, 2013
Record last verified: 2013-05