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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified December 2013 by University Hospital, Ghent
Sponsor:
Information provided by (Responsible Party):
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT02010424
First received: December 9, 2013
Last updated: December 16, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention
Fertility
Other: control group
Device: Primo Vision embryo culture dish (CE labeled, Vitrolife)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:
  • Blastocyst utilisation rate [ Time Frame: 5 days after fertilization ] [ Designated as safety issue: No ]
    number of blastocysts out of fertilized oocytes observed 5 days after fertilization that can be used for the patient (fresh transfer or cryopreservation)


Secondary Outcome Measures:
  • Morphologic evaluation [ Time Frame: 5 days after fertilization ] [ Designated as safety issue: No ]
    Morphologic evaluation according to the Gardner score (Gardner and Schoolcraft, 1999)

  • change in embryo development [ Time Frame: at day 2, 3 and 4 after fertilization ] [ Designated as safety issue: No ]
    morphologic evaluation at day 2, 3 and 4 after fertilization

  • pregnancy rate [ Time Frame: day 15 and week 5 after embryo transfer ] [ Designated as safety issue: No ]
    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 [ Time Frame: 9 months after embryo transfer ] [ Designated as safety issue: No ]
    birth of a baby nine months after embryo transfer

  • change in secretome [ Time Frame: day 3 and day 5 after fertilization ] [ Designated as safety issue: No ]
    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).


Estimated Enrollment: 158
Study Start Date: January 2014
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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
Other: control group
standard IVF protocol
Experimental: 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
Device: Primo Vision embryo culture dish (CE labeled, Vitrolife)

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

-

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02010424

Contacts
Contact: Petra De Sutter, PhD, MD 0032 9 3323750

Locations
Belgium
Antwerp University Hospital, Centre for Reproductive Medicine Not yet recruiting
Edegem, Belgium, 2650
Contact: Delbeke, Prof. Dr.         
Principal Investigator: Prof. Dr. Delbeke         
Ghent University Hospital Not yet recruiting
Ghent, Belgium, 9000
Contact: Petra De Sutter, PhD, MD         
Principal Investigator: Petra De Sutter, PhD MD         
Sponsors and Collaborators
University Hospital, Ghent
  More Information

No publications provided

Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT02010424     History of Changes
Other Study ID Numbers: 2013/819
Study First Received: December 9, 2013
Last Updated: December 16, 2013
Health Authority: Belgium: Institutional Review Board

Keywords provided by University Hospital, Ghent:
reduced fertility

ClinicalTrials.gov processed this record on October 20, 2014