Can near infrared (NIR) spectroscopy of spent culture media from human embryos predict the embryos reproductive potential?
| ISRCTN | ISRCTN23817363 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN23817363 |
| Secondary identifying numbers | N/A |
- Submission date
- 02/07/2009
- Registration date
- 04/09/2009
- Last edited
- 18/04/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Thorir Hardarson
Scientific
Scientific
Fertility Centre, Box 5418
Gothenburg
40229
Sweden
Study information
| Study design | Double-blinded single centre randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Can be found at http://www.fertilitetscentrum.se/51.html (Swedish only) |
| 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 |
| Study objectives | 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(s) | Local ethics committee (Regionala Etikprövningsnamnden i Göteborg) approved on the 25th March 2008 (ref: 120-08) |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/06/2009 |
| Completion date | 01/09/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 752 |
| Key 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) |
| Key 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 |
| Date of first enrolment | 01/06/2009 |
| Date of final enrolment | 01/09/2011 |
Locations
Countries of recruitment
- Sweden
Study participating centre
Fertility Centre, Box 5418
Gothenburg
40229
Sweden
40229
Sweden
Sponsor information
Molecular Biometrics (MB) LLC (USA)
Industry
Industry
5 Topping Way
Chester
07930
United States of America
Funders
Funder type
Industry
Molecular Biometrics (MB) LLC (USA) - provided the NIR spectroscopic technology and provides some financial support through a research position held at the clinic
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/05/2011 | Yes | No | |
| Results article | results | 01/01/2012 | Yes | No |
