CClinicalTrials.gg
TerminatedNCT01587547EmbryoSureUpdated May 8, 2013

Amino Acid Profiling of Spent Culture Medium

An observational study in Infertility, sponsored by Origio A/S. Terminated at 2 sites in United Kingdom. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2013-05-08.

Sponsored by Origio A/S · Observational

Why this study was terminated
ORIGIO a/s acquired by Cooper Surgical Inc. who decided to withdraw from the project
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
10
Ages
18 Years to 40 Years
Sex
Female
01

Study 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 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.

02

Conditions studied

  • Infertility

Browse trials for

Keywords

  • ART
  • IVF
  • ICSI
  • embryo selection
03

In context

Infertility

2,506 studies on the registry are indexed under Infertility; 407 are open to participants now.

This study's enrollment of 10 is below the median of 200 across 714 observational studies indexed under Infertility.

Browse Infertility studies →

Lead sponsor

Origio A/S is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Subjects will be recruited from couples and single women attending the IVF clinic for IVF/ICSI treatment.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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).
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
10 participants (actual)
Biospecimen retention
Samples without dna

Groups and cohorts

  • IVF and ICSI patients

    Subjects undergoing IVF or ICSI treatment with a maximum of 2 embryos transferred

06

What researchers measure

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.

    Time frame: After 24 hours of culture

Secondary outcomes

  1. Ongoing clinical pregnancy rate

    Evaluated by ultrasound scan

    Time frame: Gestational week 7

07

Study locations

2 sites
  • The Hewitt Centre for Reproductive Medicine, Liverpool Women's Hospital
    Liverpool, L8 7SS, United Kingdom
  • Hammersmith IVF, Hammersmith Hospital
    London, W12 0HS, United Kingdom
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 8, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01587547
Lead sponsor
Origio A/S
Collaborators
Novocellus Ltd., Signifikans ApS
Responsible party
Sponsor
First posted
Apr 30, 2012
Start date
Apr 2012
Primary completion
Dec 2012
Completion
Apr 2013
Last update
May 8, 2013

Study contacts

Helen M Picton, BSc, PhD
principal investigator · Leeds Institute of Genetic Health

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in May 2013. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion