Back to resultsClinical Pregnancies After Cryopreservation of Donor Oocytes With an Open or Closed Device
Primary Purpose
Infertility
Status
Terminated
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Cryotop device
CBSvit device
Sponsored by
About this trial
This is an interventional other trial for Infertility focused on measuring oocyte cryopreservation, closed vitrification, open vitrification
Eligibility Criteria
Inclusion Criteria:
- this is a pragmatic randomized clinical trial. Hence, all consenting oocyte recipients will be eligible for the study
Exclusion Criteria:
- women who do not consent or that cannot comprehend the investigational nature of the study
Sites / Locations
- Universitair Ziekenhuis Brussel
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
closed device
open device
Arm Description
Standard cryopreservation system.
New cryopreservation system.
Outcomes
Primary Outcome Measures
Clinical pregnancy
Pregnancy determined by ultrasound
Secondary Outcome Measures
survival
oocyte survival post-warming based on the morphological appearance of the oocytes immediately after warming: degenerated oocytes are non-surviving oocytes; oocytes with a normal morphological appearance are surviving oocytes
fertilization
oocyte fertilization post-insemination: the day after oocyte insemination fertilization is checked: if one male and one female pronucleus appear, the oocyte is fertilized. if both nuclei are not present or more nuclei are present, the oocyte is considered not fertilized.
embryo development
embryo development post-fertilization: on day 3 of pre-implantation development, the embryo is scored for the number of cells, fragmentation, appearance of nuclei and other embryological parameters: based on these parameters, an embryological score is given to the embryo. On day 5 of development (blastocyst stage) another score is given to the embryo based on the appearance of the trophectoderm and inner cell mass cells.
Full Information
NCT ID
NCT02940106
First Posted
October 11, 2016
Last Updated
January 10, 2022
Sponsor
Universitair Ziekenhuis Brussel
1. Study Identification
Unique Protocol Identification Number
NCT02940106
Brief Title
Clinical Pregnancies After Cryopreservation of Donor Oocytes With an Open or Closed Device
Official Title
Investigation of the Clinical Pregnancies Obtained After Cryopreservation of Donor Oocytes With an Open or Closed Device
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Terminated
Why Stopped
enrollment too slow, too many variables included in the study
Study Start Date
October 2016 (Actual)
Primary Completion Date
July 2018 (Actual)
Study Completion Date
July 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitair Ziekenhuis Brussel
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This randomized pilot study will assess if there is a difference in clinical pregnancies using donor oocytes cryopreserved in either a closed or a semi-closed vitrification device.
Detailed Description
Oocyte cryopreservation was optimized by the use of a new technique: vitrification. Vitrification can be performed using either open devices (where the oocytes are in direct contact with the liquid nitrogen) or closed systems (where the oocytes are never in contact with liquid nitrogen). Previous studies have associated the use of open devices to higher oocyte survival rates and better embryo development. However, any beneficial effect on clinical pregnancy rates is yet to be proven. Hence, the objective of this study is to compare the clinical pregnancy rates of open and closed oocyte vitrification devices.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
oocyte cryopreservation, closed vitrification, open vitrification
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
closed device
Arm Type
Placebo Comparator
Arm Description
Standard cryopreservation system.
Arm Title
open device
Arm Type
Active Comparator
Arm Description
New cryopreservation system.
Intervention Type
Device
Intervention Name(s)
Cryotop device
Other Intervention Name(s)
Cryotop open vitrification device (Kitazato)
Intervention Description
a different device for oocyte vitrification (with a very high cooling rate)
Intervention Type
Device
Intervention Name(s)
CBSvit device
Other Intervention Name(s)
CBSvit closed vitrification device (CryoBioSystems vitrification device)
Intervention Description
a different device for oocyte vitrification (with a lower cooling rate)
Primary Outcome Measure Information:
Title
Clinical pregnancy
Description
Pregnancy determined by ultrasound
Time Frame
7 weeks
Secondary Outcome Measure Information:
Title
survival
Description
oocyte survival post-warming based on the morphological appearance of the oocytes immediately after warming: degenerated oocytes are non-surviving oocytes; oocytes with a normal morphological appearance are surviving oocytes
Time Frame
1 week
Title
fertilization
Description
oocyte fertilization post-insemination: the day after oocyte insemination fertilization is checked: if one male and one female pronucleus appear, the oocyte is fertilized. if both nuclei are not present or more nuclei are present, the oocyte is considered not fertilized.
Time Frame
1 week
Title
embryo development
Description
embryo development post-fertilization: on day 3 of pre-implantation development, the embryo is scored for the number of cells, fragmentation, appearance of nuclei and other embryological parameters: based on these parameters, an embryological score is given to the embryo. On day 5 of development (blastocyst stage) another score is given to the embryo based on the appearance of the trophectoderm and inner cell mass cells.
Time Frame
2 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
47 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
this is a pragmatic randomized clinical trial. Hence, all consenting oocyte recipients will be eligible for the study
Exclusion Criteria:
women who do not consent or that cannot comprehend the investigational nature of the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neelke De Munck, MSc.
Organizational Affiliation
Universitair Ziekenhuis Brussel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitair Ziekenhuis Brussel
City
Brussels
ZIP/Postal Code
1090
Country
Belgium
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
26724798
Citation
De Munck N, Santos-Ribeiro S, Stoop D, Van de Velde H, Verheyen G. Open versus closed oocyte vitrification in an oocyte donation programme: a prospective randomized sibling oocyte study. Hum Reprod. 2016 Feb;31(2):377-84. doi: 10.1093/humrep/dev321. Epub 2016 Jan 2.
Results Reference
background
Learn more about this trial
Clinical Pregnancies After Cryopreservation of Donor Oocytes With an Open or Closed Device
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