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

Universitair Ziekenhuis Brussel19 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Enrollment

Conditions

Infertility

Interventions

Cryotop deviceDEVICE

a different device for oocyte vitrification (with a very high cooling rate)

CBSvit deviceDEVICE

a different device for oocyte vitrification (with a lower cooling rate)

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 47 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Universitair Ziekenhuis Brussel

Brussels, Belgium

Outcomes

Primary Outcomes

Clinical pregnancy

Pregnancy determined by ultrasound

Time frame: 7 weeks

Secondary Outcomes

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

Time frame: 1 week

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.

Time frame: 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.

Time frame: 2 weeks

Data from ClinicalTrials.gov

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