Amino Acid Profiling of Spent Culture Medium

Terminated

• Conditions: Infertility

• Registration Number: NCT01587547
• Lead Sponsor: Origio A/S

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.

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 Timeline

• Study Start: 2012-04
• Study First Submitted: 2012-04-26
• Study First Submitted QC: 2012-04-26
• Study First Posted: 2012-04-30
• Primary Completion: 2012-12
• Study Completion: 2013-04
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-07
• Last Update Posted: 2013-05-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 10

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Amino acid profile	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.

Secondary Outcome Measures

Name	Time	Method
Ongoing clinical pregnancy rate	Gestational week 7	Evaluated by ultrasound scan

Trial Locations

Locations (2)

The Hewitt Centre for Reproductive Medicine, Liverpool Women's Hospital; 🇬🇧 Liverpool, United Kingdom

Hammersmith IVF, Hammersmith Hospital; 🇬🇧 London, United Kingdom