Oocyte Cryopreservation: Slow Cooling Versus Vitrification Techniques on Oocyte Survival
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|ClinicalTrials.gov Identifier: NCT00602966|
Recruitment Status : Completed
First Posted : January 28, 2008
Last Update Posted : October 28, 2011
Oocyte cryopreservation has been studied for many years without much success in refining a method that has consistent, reliable results in producing viable embryos and clinical pregnancies. In 1986 the first baby was born from an embryo created from a frozen oocyte; however, since then there have been less than 150 births from frozen eggs. To date, there are no reportable adverse outcomes in the children born from frozen oocytes. The research continues to look at different methods of oocyte cryopreservation. Many smaller studies have been conducted with some success but larger clinical trials are needed to replicate these findings. The conventional cryopreservation technique has been slow cooling with differing methods of freezing; however, vitrification is now being researched as the potential cryopreserving method that holds some promise for the future.
Our hypothesis is the use of vitrification (quick freezing) to cryopreserve oocytes in patients undergoing in-vitro fertilization will be more successful than slow freezing in oocyte survival, fertilization rate with ICSI and subsequent embryo development, implantation rate and pregnancy rate.
|Condition or disease|
Cryopreservation of oocytes is desirable because it: 1) would allow infertility patients to store excess oocytes instead of embryos, eliminating some of the ethical and religious concerns that accompany embryo storage; 2) permit storage of donor oocytes to avoid donor-recipient synchronization difficulties; and 3) can help women who may face sterilization due to chemotherapy or radiation. Oocyte cryopreservation is therefore gaining in popularity as an option for infertility treatment as well as fertility preservation.
Oocyte cryopreservation using conventional slow-cooling methods has not had much success; however more recent results have provided more optimism (Boldt et al., 2003; Porcu et al., 1997; 2000; 2002; Yang et al., 1998; 1999; 2002; Winslow et al., 2001). Vitrification has also been employed (Hong et al., 1999; Kuleshova et al., 1999; Yoon et al., 2000, 2003; Chung et al 2000; Wu et al., 2001: Kuwayama et al., 2005) with increased oocyte survival rate and live births. Vitrification is performed by suspending the oocytes in a solution containing a high concentration of cryoprotectants and then plunging them directly into liquid nitrogen (Rall and Fahy, 1985). The advantage of this technique is to prevent the formation of ice crystals within the oocyte. However the toxic effect of the high concentration of the cryoprotectant media has been a concern. New vitrification techniques which attempt to accelerate the cooling rate by decreasing the cryosolution volume and concentration, may reduce the potential toxicity. In addition, a more rapid cooling rate results in reduced chilling injury (Vajta et al., 1998).
|Study Type :||Observational|
|Actual Enrollment :||14 participants|
|Observational Model:||Case Control|
|Official Title:||Oocyte Cryopreservation: Comparison of Slow Cooling Versus Vitrification Techniques on Oocyte Survival, Fertilization, and Embryo Development|
|Study Start Date :||July 2006|
|Actual Primary Completion Date :||October 2009|
|Actual Study Completion Date :||May 2010|
- Oocyte survival [ Time Frame: When patient returns for thaw cycle ]
- Implantation rate [ Time Frame: 2 weeks after transfer of thawed oocyte ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00602966
|United States, Connecticut|
|The Center for Advanced Reproductive Services|
|Farmington, Connecticut, United States, 06030-6224|
|Principal Investigator:||Claudio Benadiva, MD, HCLD||The Center for Advanced Reproductive Services, P.C.|