Infertility
Conditions
Keywords
oocyte cryopreservation, closed vitrification, open vitrification
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.
Interventions
DEVICECryotop device
a different device for oocyte vitrification (with a very high cooling rate)
DEVICECBSvit device
a different device for oocyte vitrification (with a lower cooling rate)
Sponsors
Universitair Ziekenhuis Brussel
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 47 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical pregnancy | 7 weeks | Pregnancy determined by ultrasound |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Belgium
Outcome results
None listed