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Randomized Controlled Trial Comparing Slow-freezing to Vitrification of Oocytes

Cryopreservation of Oocytes: A Randomized Controlled Trial Comparing Slow-freezing to Vitrification

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00777387
Enrollment
14
Registered
2008-10-22
Start date
2008-08-31
Completion date
2014-01-31
Last updated
2014-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility

Keywords

human oocyte cryopreservation, slow-freeze, vitrification

Brief summary

Preservation of fertility is limited. Current methods include embryo cryopreservation and while still experimental, ovarian cryopreservation. In single women who are at risk for infertility secondary to cancer or couples who have ethical reasons to avoid embryo cryopreservation, oocyte cryopreservation is an alternative Purpose of study is to compare slow freeze to vitrification of human oocytes. Successful cryopreservation and subsequent thawing programs are characterized by avoiding ice crystal formation.Vitrification, newer alternative to slow freeze method, process by which water is prevented from forming ice. Our hypothesis is that higher survival rate per oocyte is to be expected in the vitrification group.

Detailed description

Although several reviews of smaller studies of cryoprotectant methodology exist randomized controlled trials,comparing slow-freeze-rapid-thaw procedure to vitrification of oocytes, are not available. The purpose of this study is to compare these two methods of oocyte cryopreservation in human oocytes.

Interventions

PROCEDUREslow-freeze

Slow-freeze-rapid-thaw procedure of oocytes is characterized by prolonged exposure of the cell to cryoprotectants in a low metabolic state at very low temperatures

PROCEDUREvitrification

Vitrification is the process by which water is prevented from forming ice due to the viscosity of a highly concentrated cryoprotectant cooled at an extremely rapid rate

Sponsors

Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 37 Years
Healthy volunteers
Yes

Inclusion criteria

* 14 or more oocytes at ovum pick up * age \< 38 * bmi \< 30

Exclusion criteria

\-

Design outcomes

Primary

MeasureTime frame
post-thaw oocyte survival rate2 years

Secondary

MeasureTime frame
fertilization rate2 years
cleavage2 years
embryo development2 years
implantation rate2 years
ongoing pregnancy2 years

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026