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

NCT ID: NCT02010424

Last Updated: 2022-12-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 158 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2015-12-31

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.

Conditions

Fertility

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Individual culture

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

Group Type: EXPERIMENTAL

control group

Intervention Type: OTHER

standard IVF protocol

WOW

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

Group Type: EXPERIMENTAL

Primo Vision embryo culture dish (CE labeled, Vitrolife)

Intervention Type: DEVICE

Interventions

control group

standard IVF protocol

Intervention Type: OTHER

Primo Vision embryo culture dish (CE labeled, Vitrolife)

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

-

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Ghent

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Antwerp University Hospital, Centre for Reproductive Medicine

Edegem, , Belgium

Ghent University Hospital

Ghent, , Belgium

Countries

Belgium

Other Identifiers

2013/819

Identifier Type: -

Identifier Source: org_study_id