Not provided
Not provided
Not provided
Not provided
Not provided
enrollment too slow, too many variables included in the study
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| closed device | Placebo Comparator | Standard cryopreservation system. |
|
| open device | Active Comparator | New cryopreservation system. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cryotop device | Device | a different device for oocyte vitrification (with a very high cooling rate) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical pregnancy | Pregnancy determined by ultrasound | 7 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 1 week |
| fertilization |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Neelke De Munck, MSc. | Universitair Ziekenhuis Brussel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitair Ziekenhuis Brussel | Brussels | 1090 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26724798 | Background | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| CBSvit device | Device | a different device for oocyte vitrification (with a lower cooling rate) |
|
|
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. |
| 1 week |
| 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. | 2 weeks |