Clinical Pregnancies After Cryopreservation of Donor Oocytes With an Open or Closed Device
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Placebo Comparator: closed device Standard cryopreservation system. |
Device: CBSvit device
a different device for oocyte vitrification (with a lower cooling rate)
Other Names:
|
| Active Comparator: open device New cryopreservation system. |
Device: Cryotop device
a different device for oocyte vitrification (with a very high cooling rate)
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Clinical pregnancy [7 weeks]
Pregnancy determined by ultrasound
Secondary Outcome Measures
- survival [1 week]
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 [1 week]
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 [2 weeks]
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.
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Universitair Ziekenhuis Brussel | Brussels | Belgium | 1090 |
Sponsors and Collaborators
- Universitair Ziekenhuis Brussel
Investigators
- Principal Investigator: Neelke De Munck, MSc., Universitair Ziekenhuis Brussel
Study Documents (Full-Text)
None provided.More Information
Publications
- 2016/245