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

Fertility Clinical Trial

— WOW  

Official title:

Multicentric Clinical Trial to Improve Blastocyst Utilisation Rate (in Relation to 2 PN Embryos) by Group Culture of Human Embryos in WOW Dishes.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02010424
• Other study ID #: 2013/819
• Status: Completed
• Phase: N/A
• Start date: January 2014
• Est. completion date: December 2015

Study information

• Verified date: November 2022
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 158
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Sperm obtained by ejaculation

• Conventional IVF/ICSI

• At least 10 fertilized oocytes (2 PN)

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Fertility

Intervention

Other:
• control group
standard IVF protocol

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

Locations

Country	Name	City	State
Belgium	Antwerp University Hospital, Centre for Reproductive Medicine	Edegem
Belgium	Ghent University Hospital	Ghent

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Morphologic evaluation	Morphologic evaluation according to the Gardner score (Gardner and Schoolcraft, 1999)	5 days after fertilization
Secondary	change in embryo development	morphologic evaluation at day 2, 3 and 4 after fertilization	at day 2, 3 and 4 after fertilization
Secondary	pregnancy rate	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.	day 15 and week 5 after embryo transfer
Secondary	life birth rate	birth of a baby nine months after embryo transfer	9 months after embryo transfer
Secondary	change in secretome	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).	day 3 and day 5 after fertilization