Amino Acid Profiling of Spent Culture Medium (EmbryoSure)

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.

Study Overview

• Status: Terminated
• Conditions: Infertility

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 Type: Observational
• Enrollment (Actual): 10

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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:

• 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).

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
IVF and ICSI patients; Subjects undergoing IVF or ICSI treatment with a maximum of 2 embryos transferred

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ongoing clinical pregnancy rate	Evaluated by ultrasound scan	Gestational week 7

Collaborators and Investigators

• Sponsor: Origio A/S
• Collaborators: Signifikans ApS; Novocellus Ltd.
• Investigators: Principal Investigator: Helen M Picton, BSc, PhD, Leeds Institute of Genetic Health

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): April 1, 2013

Study Registration Dates

• First Submitted: April 26, 2012
• First Submitted That Met QC Criteria: April 26, 2012
• First Posted (Estimate): April 30, 2012

Study Record Updates

• Last Update Posted (Estimate): May 8, 2013
• Last Update Submitted That Met QC Criteria: May 7, 2013
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Keywords: IVF; ART; ICSI; embryo selection
• Additional Relevant MeSH Terms: Infertility
• Other Study ID Numbers: DK005; CI/2010/0041 (Other Identifier: Medicines & Healthcare products Regulatory Agency (MHRA))