Infertility
Conditions
Keywords
Oocyte vitrification, survival rate, egg banking, ovum donation
Brief summary
This study is aimed to evaluate the use of a closed device for storage of vitrified oocytes.
Detailed description
The Cryotop method for oocyte vitrification is classified as open system, which means that it requires direct contact with liquid nitrogen during the vitrification process. The system has an external straw to protect the samples during storage, but the device is not hermetically sealed. Instead closed systems are devices that are hermetically sealed before vitrification and remain sealed during storage. Open systems have proven highly effective in achieving similar outcomes with vitrified oocytes compared to those achieved with fresh ones. On the contrary, closed systems have failed to be as effective as open ones when used for oocyte vitrification. Although open systems have proven to be highly efficient, where many other methods have failed, they have been related to a theoretical risk of contamination due to direct contact with liquid nitrogen. Though to date there have been no reported cases of transmission of disease after cryo-transfers either for slow freezing or vitrification, some European countries prohibit the use of open systems for vitrification. In this study, we will evaluate the results after the donor oocyte vitrification, using a modification of a current device (Cryotop®), which makes it capable of being hermetically sealed. The current study is a prospective randomized trial aimed to assess the outcome of ovum donation cycles conducted with vitrified oocytes using the closed device versus oocytes vitrified using the traditional open device.
Interventions
PROCEDUREOocytes are vitrified/stored using a closed device
Vitrification will be carried out using a modification of the current device (Cryotop®), thus providing air tight sealing. Closed systems are devices that are hermetically sealed before vitrification and remain sealed during storage.
PROCEDUREOocytes are vitrified/stored using an open device
The vitrification process takes place through direct contact with liquid nitrogen. The system has an external straw to protect the samples during storage, but the device is not hermetically sealed.
Sponsors
Instituto Valenciano de Infertilidad, IVI VALENCIA
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
Donors: * \< 35 years old * Normal physical and gynecological examinations * No family history of hereditary or chromosomal diseases. * Normal karyotype * Negative screening for sexually transmitted diseases. Oocyte recipients: * Oocyte recipients \< 50 years old * Body mass index \< 30 * \< 2 previous IVF failures * No severe male factor * No recurrent miscarriage * No hidrosalpinx * No myoma * No adenomyosis * No AMH alterations
Exclusion criteria
Donors and recipients not meeting inclusion criteria
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Survival after oocyte vitrification using the closed device Cryotop® | >2 hours | Survival will be evaluated morphologically two hours after warming. |
Secondary
| Measure | Time frame |
|---|---|
| Embryo development | From thawing and until pregnancy outcome (0-9 months) |
Countries
Spain
Outcome results
None listed