Evaluation of Group Culture in WOW Dishes of Human Embryos in Order to Optimize the Single Embryo Transfer (SET) Strategy.

Ghent University Hospital (UZ)

Status: Completed

Conditions: Fertility

Treatments: Other: control group; Device: Primo Vision embryo culture dish (CE labeled, Vitrolife)

Study type: Interventional

Funder types: Other

Identifiers

NCT02010424

2013/819

Details and patient eligibility

About

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.

Enrollment: 158 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Sperm obtained by ejaculation
• Conventional IVF/ICSI
• At least 10 fertilized oocytes (2 PN)

Exclusion criteria

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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158 participants in 2 patient groups

Individual culture

Experimental group

Description:

standard IVF protocol: half of the fertilized oocytes of the patient will be cultured individually in drops of 25 µl Cook cleavage medium till day 3 after fertilization and subsequently in drops of 25 µl Cook blastocyst medium till day 5 after fertilization

Treatment:

Other: control group

WOW

Experimental group

Description:

Half of the fertilized oocytes of the patient will be cultured in group in a WOW dish, each in a separate microwell but covered with one drop of 30 µl of Cook cleavage medium till day 3 after fertilization and subsequently all the embryos will be transferred to a new WOW dish (in the exactly the same position) covered with 30 µl of Cook blastocyst medium till day 5 after fertilization

Treatment:

Device: Primo Vision embryo culture dish (CE labeled, Vitrolife)