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Trial NCT00602966

Resource URI: http://static.linkedct.org/resource/trials/NCT00602966
linkedct:arm_group <http://static.linkedct.org/resource/arm_group/61341>
linkedct:arm_group <http://static.linkedct.org/resource/arm_group/64826>
linkedct:biospec_retention None Retained
linkedct:brief_title Oocyte Cryopreservation: Slow Cooling Versus Vitrification Techniques on Oocyte Survival
linkedct:collaborator_agency <http://static.linkedct.org/resource/collabagency/2479>
linkedct:condition <http://static.linkedct.org/resource/condition/6601>
linkedct:criteria Inclusion Criteria: - Patients  36 years old - Day #3 follicle stimulation hormone (FSH) < 10mIU/ml, and Estradiol < 70 pg/ml. - The study will be limited to couples who do not wish to cryopreserve excess embryos, who would otherwise have their excess oocytes discarded. - Body Mass Index (BMI)  35 - Patients currently being seen in our offices Exclusion Criteria: - Male partner requiring microsurgical epididymal sperm aspiration or testicular sperm extraction (MESA/TESE) for sperm retrieval - Day #3 follicle stimulation hormone (FSH) > 10mIU/ml, or estradiol > 70 pg/ml - Diagnosis of Polycystic Ovary Syndrome (PCOS) - Body Mass Index (BMI) >35
linkedct:description 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).
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Female
linkedct:eligibility_healthy_volunteers Accepts Healthy Volunteers
linkedct:eligibility_maximum_age 36 Years
linkedct:eligibility_minimum_age 21 Years
linkedct:eligibility_sampling_method Probability Sample
linkedct:eligibility_study_pop The Center for Advanced Reproductive Services patient population
linkedct:end_date January 2010
linkedct:enrollment 30 (xsd:int)
linkedct:firstreceived_date January 15, 2008
linkedct:has_dmc No
linkedct:id NCT00602966
rdfs:label Trial NCT00602966
linkedct:lastchanged_date September 12, 2009
linkedct:lead_sponsor_agency University of Connecticut Health Center
linkedct:location <http://static.linkedct.org/resource/location/149737>
linkedct:nct_id NCT00602966
linkedct:number_of_arms 0 (xsd:int)
linkedct:number_of_groups 2 (xsd:int)
linkedct:official_title Oocyte Cryopreservation: Comparison of Slow Cooling Versus Vitrification Techniques on Oocyte Survival, Fertilization, and Embryo Development
linkedct:org_study_id 06-336-2
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/10175>
linkedct:overall_status Active, not recruiting
linkedct:oversight <http://static.linkedct.org/resource/oversight/2938>
foaf:page <http://clinicaltrials.gov/show/NCT00602966>
linkedct:phase N/A
linkedct:primary_completion_date October 2009
linkedct:primary_outcomes <http://static.linkedct.org/resource/primary_outcomes/78923>
linkedct:reference <http://static.linkedct.org/resource/reference/13755>
linkedct:reference <http://static.linkedct.org/resource/reference/17506>
linkedct:reference <http://static.linkedct.org/resource/reference/38624>
linkedct:reference <http://static.linkedct.org/resource/reference/42105>
linkedct:reference <http://static.linkedct.org/resource/reference/45993>
linkedct:reference <http://static.linkedct.org/resource/reference/5033>
linkedct:reference <http://static.linkedct.org/resource/reference/53164>
linkedct:reference <http://static.linkedct.org/resource/reference/54803>
linkedct:reference <http://static.linkedct.org/resource/reference/55840>
linkedct:reference <http://static.linkedct.org/resource/reference/6001>
linkedct:reference <http://static.linkedct.org/resource/reference/8998>
linkedct:secondary_id 26525
linkedct:secondary_outcomes <http://static.linkedct.org/resource/secondary_outcomes/54627>
linkedct:source University of Connecticut Health Center
linkedct:start_date July 2006
linkedct:study_design Case Control, Prospective
linkedct:study_type Observational
linkedct:summary 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.
rdf:type linkedct:trials
linkedct:verification_date September 2009