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

NCT02010424 | Completed

• 1 other identifier: 2013/819
• Study Type: interventional
• Target: 158
• Locations: 1 country
• Sites: 2

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

Keywords

reduced fertility

Outcome Measures

Primary Outcomes (1)

• Blastocyst utilisation rate

  number of blastocysts out of fertilized oocytes observed 5 days after fertilization that can be used for the patient (fresh transfer or cryopreservation)

  5 days after fertilization

Secondary Outcomes (5)

• Morphologic evaluation

  5 days after fertilization

• change in embryo development

  at day 2, 3 and 4 after fertilization

• pregnancy rate

  day 15 and week 5 after embryo transfer

• life birth rate

  9 months after embryo transfer

• change in secretome

  day 3 and day 5 after fertilization

Study Arms (2)

Individual culture

EXPERIMENTAL

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

Other: control group

WOW

EXPERIMENTAL

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

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

Interventions

control group OTHER

standard IVF protocol

Individual culture

Primo Vision embryo culture dish (CE labeled, Vitrolife) DEVICE

WOW

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

Sponsors & Collaborators

• University Hospital, Ghent: lead

Study Sites (2)

Antwerp University Hospital, Centre for Reproductive Medicine

Edegem, 2650, Belgium

Location

Ghent University Hospital

Ghent, 9000, Belgium

Location

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2013
• First Posted: December 12, 2013
• Study Start: January 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: December 2, 2022

Record last verified: 2022-11

Locations

BE (2)