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

Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02940106
• Other study ID #: 2016/245
• Status: Terminated
• Phase: N/A
• Start date: October 2016
• Est. completion date: July 2018

Study information

• Verified date: January 2022
• Source: Universitair Ziekenhuis Brussel
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 19
• Est. completion date: July 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 47 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility

Intervention

Device:
• Cryotop device
a different device for oocyte vitrification (with a very high cooling rate)
• CBSvit device
a different device for oocyte vitrification (with a lower cooling rate)

Locations

Country	Name	City	State
Belgium	Universitair Ziekenhuis Brussel	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Universitair Ziekenhuis Brussel

Country where clinical trial is conducted

Belgium, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical pregnancy	Pregnancy determined by ultrasound	7 weeks
Secondary	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
Secondary	fertilization	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
Secondary	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