Investigation of the Clinical Pregnancies Obtained After Cryopreservation of Donor Oocytes With an Open or Closed Device
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Enrollment
- 19
- Locations
- 1
- Primary Endpoint
- Clinical pregnancy
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Other
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 47 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
closed device
Standard cryopreservation system.
Intervention: CBSvit device (Device)
open device
New cryopreservation system.
Intervention: Cryotop device (Device)
Outcomes
Primary Outcomes
Clinical pregnancy
Time Frame: 7 weeks
Pregnancy determined by ultrasound
Secondary Outcomes
- survival(1 week)
- fertilization(1 week)
- embryo development(2 weeks)
Investigators
Neelke De Munck
Master in Science
Universitair Ziekenhuis Brussel