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 |
| Protocol serial number | N/A |
| Sponsor | Molecular Biometrics (MB) LLC (USA) |
| Funder | Molecular Biometrics (MB) LLC (USA) - provided the NIR spectroscopic technology and provides some financial support through a research position held at the clinic |
- 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
Plain English summary of protocol
Not provided at time of registration
Contact information
Scientific
Fertility Centre, Box 5418
Gothenburg
40229
Sweden
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Double-blinded single centre randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| 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(s) |
Number of ongoing pregnancies per randomised patient (intention to treat), based on fetal heart activity by means of ultrasound 45 days after embryo transfer. |
| Key secondary outcome measure(s) |
1. Total number of positive pregnancy tests per randomised patient, 18 days after embryo test |
| Completion date | 01/09/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 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
40229
Sweden
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
