Clinical trial NCT00777387: Randomized Controlled Trial Comparing Slow-freezing to Vitrification of Oocytes
Official title: Cryopreservation of Oocytes: A Randomized Controlled Trial Comparing Slow-freezing to Vitrification
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Infertility
Keywords: human oocyte cryopreservation
slow-freeze
vitrification
Lead sponsor: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Sponsor class: OTHER
First posted: 2008-10-22
Enrollment: 14
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 37
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

-

Primary outcomes:
measure: post-thaw oocyte survival rate
timeFrame: 2 years
Secondary outcomes:
measure: fertilization rate
timeFrame: 2 years
measure: cleavage
timeFrame: 2 years
measure: embryo development
timeFrame: 2 years
measure: implantation rate
timeFrame: 2 years
measure: ongoing pregnancy
timeFrame: 2 years
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
Study officials:
affiliation: Mount Sinai Hospital, Canada
name: Ellen M Greenblatt, MD, FRCS(C)
role: STUDY_DIRECTOR
References:
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citation: Porcu E, Fabbri R, Damiano G, Giunchi S, Fratto R, Ciotti PM, Venturoli S, Flamigni C. Clinical experience and applications of oocyte cryopreservation. Mol Cell Endocrinol. 2000 Nov 27;169(1-2):33-7. doi: 10.1016/s0303-7207(00)00348-8.
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