Clinical trial NCT01587547: Amino Acid Profiling of Spent Culture Medium
Official title: Amino Acid Profiling of Spent Culture Medium to Retrospectively Determine Individual Embryo Selection Criteria for Improved Clinical IVF Outcome
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Infertility
Keywords: ART
IVF
ICSI
embryo selection
Lead sponsor: Origio A/S
Sponsor class: INDUSTRY
Collaborators: name: Novocellus Ltd.
name: Signifikans ApS
First posted: 2012-04-30
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects will be recruited from couples and single women attending the IVF clinic for IVF/ICSI treatment.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Amino acid profile
timeFrame: After 24 hours of culture
Secondary outcomes:
measure: Ongoing clinical pregnancy rate
timeFrame: Gestational week 7
Other outcomes:
Locations:
city: Liverpool
country: United Kingdom
facility: The Hewitt Centre for Reproductive Medicine, Liverpool Women's Hospital
city: London
country: United Kingdom
facility: Hammersmith IVF, Hammersmith Hospital
Study officials:
affiliation: Leeds Institute of Genetic Health
name: Helen M Picton, BSc, PhD
role: PRINCIPAL_INVESTIGATOR
References: