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

• Sponsor: University Hospital, Ghent (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02010424
• Collaborator: (none)
• Enrollment: 158
• Locations: 2
• Arms: 2
• Duration (Months): 23
• Patients Per Site: 79
• Patients Per Site Per Month: 3.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Fertility	Other: control group; Device: Primo Vision embryo culture dish (CE labeled, Vitrolife)	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 158 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (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.
• Study Start Date: Jan 1, 2014
• Anticipated Primary Completion Date: Dec 1, 2015
• Anticipated Study Completion Date: Dec 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
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)

Outcome Measures

Primary Outcome Measures

1. Blastocyst utilisation rate [5 days after fertilization]

   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

1. Morphologic evaluation [5 days after fertilization]

   Morphologic evaluation according to the Gardner score (Gardner and Schoolcraft, 1999)

2. change in embryo development [at day 2, 3 and 4 after fertilization]

   morphologic evaluation at day 2, 3 and 4 after fertilization

3. pregnancy rate [day 15 and week 5 after embryo transfer]

   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.

4. life birth rate [9 months after embryo transfer]

   birth of a baby nine months after embryo transfer

5. change in secretome [day 3 and day 5 after fertilization]

   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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Sperm obtained by ejaculation

• Conventional IVF/ICSI

• At least 10 fertilized oocytes (2 PN)

Exclusion Criteria:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Antwerp University Hospital, Centre for Reproductive Medicine	Edegem		Belgium	2650
2	Ghent University Hospital	Ghent		Belgium	9000

Sponsors and Collaborators

• University Hospital, Ghent

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital, Ghent
• ClinicalTrials.gov Identifier: NCT02010424
• Other Study ID Numbers: 2013/819
• First Posted: Dec 12, 2013
• Last Update Posted: Dec 5, 2014
• Last Verified: Dec 1, 2014

• Keywords provided by University Hospital, Ghent: reduced fertility

Study Results

No Results Posted as of Dec 5, 2014