Oocyte Cryopreservation: Slow Cooling Versus Vitrification Techniques on Oocyte Survival
NCT ID: NCT00602966
Last Updated: 2011-10-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
14 participants
OBSERVATIONAL
2006-07-31
2010-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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).
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_CONTROL
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Slow Freeze
No interventions assigned to this group
Vitrification
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* Day #3 follicle stimulation hormone (FSH) \> 10mIU/ml, or estradiol \> 70 pg/ml
* Diagnosis of Polycystic Ovary Syndrome (PCOS)
* Body Mass Index (BMI) \>35
21 Years
36 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
EMD Serono
INDUSTRY
UConn Health
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Claudio Benadiva
Laboratory Director and Director of the Preimplantation Genetics Diagnosis Program,
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Claudio Benadiva, MD, HCLD
Role: PRINCIPAL_INVESTIGATOR
The Center for Advanced Reproductive Services, P.C.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
The Center for Advanced Reproductive Services
Farmington, Connecticut, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Boldt J, Cline D, McLaughlin D. Human oocyte cryopreservation as an adjunct to IVF-embryo transfer cycles. Hum Reprod. 2003 Jun;18(6):1250-5. doi: 10.1093/humrep/deg242.
Carroll J, Depypere H, Matthews CD. Freeze-thaw-induced changes of the zona pellucida explains decreased rates of fertilization in frozen-thawed mouse oocytes. J Reprod Fertil. 1990 Nov;90(2):547-53. doi: 10.1530/jrf.0.0900547.
Fuku E, Xia L, Downey BR. Ultrastructural changes in bovine oocytes cryopreserved by vitrification. Cryobiology. 1995 Apr;32(2):139-56. doi: 10.1006/cryo.1995.1013.
Hong SW, Chung HM, Lim JM, Ko JJ, Yoon TK, Yee B, Cha KY. Improved human oocyte development after vitrification: a comparison of thawing methods. Fertil Steril. 1999 Jul;72(1):142-6. doi: 10.1016/s0015-0282(99)00199-5.
Kuleshova L, Gianaroli L, Magli C, Ferraretti A, Trounson A. Birth following vitrification of a small number of human oocytes: case report. Hum Reprod. 1999 Dec;14(12):3077-9. doi: 10.1093/humrep/14.12.3077.
Porcu E, Fabbri R, Seracchioli R, Ciotti PM, Magrini O, Flamigni C. Birth of a healthy female after intracytoplasmic sperm injection of cryopreserved human oocytes. Fertil Steril. 1997 Oct;68(4):724-6. doi: 10.1016/s0015-0282(97)00268-9.
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.
Rall WF, Fahy GM. Ice-free cryopreservation of mouse embryos at -196 degrees C by vitrification. Nature. 1985 Feb 14-20;313(6003):573-5. doi: 10.1038/313573a0.
Stachecki JJ, Cohen J, Willadsen S. Detrimental effects of sodium during mouse oocyte cryopreservation. Biol Reprod. 1998 Aug;59(2):395-400. doi: 10.1095/biolreprod59.2.395.
Stachecki JJ, Cohen J, Willadsen SM. Cryopreservation of unfertilized mouse oocytes: the effect of replacing sodium with choline in the freezing medium. Cryobiology. 1998 Dec;37(4):346-54. doi: 10.1006/cryo.1998.2130.
Stachecki JJ, Cohen J, Schimmel T, Willadsen SM. Fetal development of mouse oocytes and zygotes cryopreserved in a nonconventional freezing medium. Cryobiology. 2002 Feb;44(1):5-13. doi: 10.1016/S0011-2240(02)00007-X.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
26525
Identifier Type: -
Identifier Source: secondary_id
06-336-2
Identifier Type: -
Identifier Source: org_study_id