Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
The use of near infrared (NIR) spectroscopy of culture media from human embryos to predict the embryos reproductive potential: a double-blinded randomised controlled trial
Acronym
Study hypothesis
To find out if near infrared (NIR) spectroscopy of culture media from human embryos combined with morphology better predict an embryos reproductive potential than embryo morphology alone.
Ethics approval
Local ethics committee (Regionala Etikprövningsnamnden i Göteborg) approved on the 25th March 2008 (ref: 120-08)
Study design
Double-blinded single centre randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Can be found at http://www.fertilitetscentrum.se/51.html (Swedish only)
Condition
Infertility
Intervention
1. Intervention arm: Embryos for transfer will be chosen by performing a morphological evaluation of the embryos and an analysis of the culture media by NIR
2. Control arm: Embryos for transfer will be chosen solely based on morphology
The duration of the "treatment" is 30 minutes per couple. The total follow-up time is 7 weeks after embryo transfer per patient.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Number of ongoing pregnancies per randomised patient (intention to treat), based on fetal heart activity by means of ultrasound 45 days after embryo transfer.
Secondary outcome measures
1. Total number of positive pregnancy tests per randomised patient, 18 days after embryo test
2. Number on ongoing pregnancies per randomised patient, based on fetal heart activity by means of ultrasound 45 days after embryo transfer on day 2
3. Number on ongoing pregnancies per randomised patient, based on fetal heart activity by means of ultrasound 45 days after embryo transfer on day 5
4. Number of ongoing pregnancies per embryo randomised patient, where only those embryos reaching the threshold level of viability from the NIR analysis will be included
Overall trial start date
01/06/2009
Overall trial end date
01/09/2011
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. All patients seeking IVF at Fertitlity Center Scandinavia, Gothenburg, Sweden
2. Signed an informed written consent to participate in the study
3. Aged 25 - 45 years, male and female (couple entering an IVF treatment)
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
752
Participant exclusion criteria
1. Previously randomised in the study
2. On the day of embryo transfer (culture day 2 or 5) the couple must have at least 2 embryos of good morphological quality (GQE)
3. Only single embryo transfer is allowed
4. Testicular biopsy patients (testicular sperm aspiration [TESA]/testicular sperm extraction [TESE])
5. Embryo transfer on day 3 or day 4
Recruitment start date
01/06/2009
Recruitment end date
01/09/2011
Locations
Countries of recruitment
Sweden
Trial participating centre
Fertility Centre, Box 5418
Gothenburg
40229
Sweden
Funders
Funder type
Industry
Funder name
Molecular Biometrics (MB) LLC (USA) - provided the NIR spectroscopic technology and provides some financial support through a research position held at the clinic
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21397559
2. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22068638
Publication citations
-
Results
Ahlström A, Wikland M, Rogberg L, Barnett JS, Tucker M, Hardarson T, Cross-validation and predictive value of near-infrared spectroscopy algorithms for day-5 blastocyst transfer., Reprod. Biomed. Online, 2011, doi: 10.1016/j.rbmo.2011.01.009.
-
Results
Hardarson T, Ahlström A, Rogberg L, Botros L, Hillensjö T, Westlander G, Sakkas D, Wikland M, Non-invasive metabolomic profiling of Day 2 and 5 embryo culture medium: a prospective randomized trial., Hum. Reprod., 2012, 27, 1, 89-96, doi: 10.1093/humrep/der373.