Amino Acid Profiling of Spent Culture Medium

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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01587547

Acronym

EmbryoSure

Enrollment

Registered

2012-04-30

Start date

2012-04-30

Completion date

2013-04-30

Last updated

2013-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility

Keywords

ART, IVF, ICSI, embryo selection

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 40 Years

Healthy volunteers

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).

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

United Kingdom

Outcome results