Fertility
Conditions
Keywords
reduced fertility
Brief summary
In cattle less than 10% of the embryos develop to the blastocyst stage when embryos are cultured individually, however when bovine embryos are cultured in groups a typical 25-35% of blastocysts can be observed. This tendency, i.e. improved embryo development in group culture, has also been demonstrated in other mammalian species, such as mouse, cat and human. The main reason for this beneficial outcome of group culture has been ascribed to the presence of autocrine factors, which are factors secreted by preimplantation embryos that act upon the embryo itself or the neighboring embryos . Although group culture systems are common in in vitro production systems for animal embryos, it is rarely done in human settings, where individual follow-up of the embryo during the whole culture period is of utmost importance. Recently a CE-labelled culture device has been designed for human embryos, that allow to combine the benefits of both group culture approaches and individual culture. The WOW dish is commercially available by Primo Vision and consists of 9 small microwells on the bottom of the plate, so that the embryos can be cultivated individually in a microwell, but covered by the same drop of culture medium. In this clinical randomized trial, 158 patients will be included of which half of the fertilized oocytes will be cultured individually (standard culture system) and half of the fertilized oocytes will be cultured in group in a WOW dish, both during five days of culture. The aim of this study is to increase the number of blastocysts suitable for transfer or cryopreservation by culturing the embryos in WOW dishes.
Interventions
OTHERcontrol group
standard IVF protocol
DEVICEPrimo Vision embryo culture dish (CE labeled, Vitrolife)
Sponsors
University Hospital, Ghent
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* Sperm obtained by ejaculation * Conventional IVF/ICSI * At least 10 fertilized oocytes (2 PN)
Exclusion criteria
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blastocyst utilisation rate | 5 days after fertilization | number of blastocysts out of fertilized oocytes observed 5 days after fertilization that can be used for the patient (fresh transfer or cryopreservation) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Morphologic evaluation | 5 days after fertilization | Morphologic evaluation according to the Gardner score (Gardner and Schoolcraft, 1999) |
| change in embryo development | at day 2, 3 and 4 after fertilization | morphologic evaluation at day 2, 3 and 4 after fertilization |
| pregnancy rate | day 15 and week 5 after embryo transfer | endocrine pregnancy by measuring hCG in blood sample on day 15 after embryo transfer and clinical pregnancy confirmed by ultrasound, 5 weeks after embryo transfer. |
| life birth rate | 9 months after embryo transfer | birth of a baby nine months after embryo transfer |
| change in secretome | day 3 and day 5 after fertilization | embryo conditioned medium will we collected at day 3 and day 5 after fertilization in eppendorf tubes and kept in -80°C until all samples are collected and they will be analyzed with mass spectrometry to compare the secretome (secreted proteins by the preimplantation embryo). |
Countries
Belgium
Outcome results
None listed