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

Not Applicable

Terminated

• Conditions: Infertility
• Interventions: Device: CBSvit device; Device: Cryotop device

• Registration Number: NCT02940106
• Lead Sponsor: Universitair Ziekenhuis Brussel

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.

Study Timeline

• Study Start: 2016-10
• Study First Submitted: 2016-10-11
• Study First Submitted QC: 2016-10-18
• Study First Posted: 2016-10-20
• Primary Completion: 2018-07
• Study Completion: 2018-07
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-10
• Last Update Posted: 2022-01-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 19

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
closed device	CBSvit device	Standard cryopreservation system.
open device	Cryotop device	New cryopreservation system.

Primary Outcome Measures

Name	Time	Method
Clinical pregnancy	7 weeks	Pregnancy determined by ultrasound

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Universitair Ziekenhuis Brussel; 🇧🇪 Brussels, Belgium