Condition category
Pregnancy and Childbirth
Date applied
02/07/2009
Date assigned
04/09/2009
Last edited
18/04/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Thorir Hardarson

ORCID ID

Contact details

Fertility Centre
Box 5418
Gothenburg
40229
Sweden

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 measures

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

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

Sponsor information

Organisation

Molecular Biometrics (MB) LLC (USA)

Sponsor details

5 Topping Way
Chester
07930
United States of America

Sponsor type

Industry

Website

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

Results - basic reporting

Publication summary

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

  1. 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.

  2. 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.

Additional files

Editorial Notes