- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01952184
Oocyte Survival After Vitrification in an Open or Closed Device With Closed Storage.
December 2, 2015 updated by: Neelke De Munck, Universitair Ziekenhuis Brussel
Oocyte Survival After Vitrification in an Open or Closed Commercial Device: Study on Sibling Donor Oocytes.
The survival rate (and embryo quality) of donor oocytes with two commercially available devices.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Donor sibling oocytes will be vitrified with two commercially available devices.
The first device is closed vitrification with closed storage and the second device is open vitrification with closed storage.
Oocyte acceptors receive oocytes from both devices.
With the increase in cooling rate generated by the open vitrification (second device), we expect to get an increase in survival rate of 10%.
Besides this, embryo quality will be assessed with oocytes obtained from both devices.
Study Type
Interventional
Enrollment (Actual)
48
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Brussels
-
Jette, Brussels, Belgium, 1090
- Universitair Ziekenhuis Brussel
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 36 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Donor: ≤36 years old on day of oocyte retrieval
- Donor: ≥ 6 mature oocytes
Exclusion Criteria:
- Donor: < 6 mature oocytes
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: closed vitrification with closed storage
Half of the oocytes of every donor will be vitrified with the Cryo Bio Systems High Security vitrification (CBSvit HS) device; the standard device in our lab.
|
closed vitrification with closed storage
|
Experimental: open vitrification with closed storage
Half of the oocytes of every donor will be vitrified with the Cryotop closed system (Cryotop SC).
|
open vitrification with closed storage
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Survival rate
Time Frame: up to 6 days after every warming cycle
|
The purpose is to assess the survival rate of donor oocytes with the two vitrification devices.
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up to 6 days after every warming cycle
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Embryo development
Time Frame: up to 6 days after every warming cycle
|
The purpose is to analyse the pre-implantation development of donor oocytes vitrified with two different devices.
|
up to 6 days after every warming cycle
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Neelke De Munck, MSc., Centrum voor Reproductieve Geneeskunde, UZBrussel
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2013
Primary Completion (Actual)
July 1, 2015
Study Completion (Actual)
July 1, 2015
Study Registration Dates
First Submitted
September 24, 2013
First Submitted That Met QC Criteria
September 26, 2013
First Posted (Estimate)
September 27, 2013
Study Record Updates
Last Update Posted (Estimate)
December 3, 2015
Last Update Submitted That Met QC Criteria
December 2, 2015
Last Verified
December 1, 2015
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2013/777
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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