Infertility Pregnancy and Childbirth Infertility
Conditions
Interventions
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 b
Sponsors
Molecular Biometrics (MB) LLC (USA)
Eligibility
Sex/Gender
All
Inclusion criteria
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)
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Sweden
Outcome results
None listed