Clinical Pregnancies After Cryopreservation of Donor Oocytes With an Open or Closed Device

Universitair Ziekenhuis Brussel

Status: Terminated

Conditions: Infertility

Treatments: Device: CBSvit device; Device: Cryotop device

Study type: Interventional

Funder types: Other

Identifiers

NCT02940106

2016/245

Details and patient eligibility

About

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.

Full 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.

Enrollment: 19 patients

Sex: Female

Ages: 18 to 47 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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19 participants in 2 patient groups, including a placebo group

closed device

Placebo Comparator group

Description:

Standard cryopreservation system.

Treatment:

Device: CBSvit device

open device

Active Comparator group

Description:

New cryopreservation system.

Treatment:

Device: Cryotop device