Amino Acid Profiling of Spent Culture Medium

Infertility Clinical Trial

— EmbryoSure  

Official title:

Amino Acid Profiling of Spent Culture Medium to Retrospectively Determine Individual Embryo Selection Criteria for Improved Clinical IVF Outcome

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01587547
• Other study ID #: DK005
• Secondary ID: CI/2010/0041
• Status: Terminated
• Phase: N/A
• First received: April 26, 2012
• Last updated: May 7, 2013
• Start date: April 2012
• Est. completion date: April 2013

Study information

• Verified date: May 2013
• Source: Origio A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited Kingdom: Research Ethics CommitteeUnited Kingdom: NHS Trust (R&D)Denmark: Danish Dataprotection Agency
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: April 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Infertility

Locations

Country	Name	City	State
United Kingdom	The Hewitt Centre for Reproductive Medicine, Liverpool Women's Hospital	Liverpool
United Kingdom	Hammersmith IVF, Hammersmith Hospital	London

Sponsors (3)

Lead Sponsor	Collaborator
Origio A/S	Novocellus Ltd., Signifikans ApS

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Ongoing clinical pregnancy rate	Evaluated by ultrasound scan	Gestational week 7	Yes