Infertility Clinical Trial
Official title:
Oocyte Cryopreservation: A Pilot Study Comparing Fertilization and Embryo Development Between Fresh and Vitrified Sibling Oocytes
Vitrification is a method to cryopreserve biological specimens that are sensitive to
chilling injury such as oocytes and embryos, and it has been employed with increased
survival rate and live births (Hong et al., 1999; Kuleshova et al., 1999; Yoon et al., 2000;
Chung et al 2000; Wu et al., 2001: Kuwayama et al 2006). In their study the researchers
propose to directly compare oocyte survival, fertilizaton and embryo development between
sibling oocytes.
The Cryotop method of vitrification, which the researchers aim to investigate in their
study, has been reported as the most efficient method for human oocytes cryopreservation
(Kuwayama et al, 2005, Antinori et al, 2006, Lucena et al, 2006, Cobo et al, 2008). Follow
up of over 200 infants conceived from vitrified oocytes (Chian et al, 2008) indicate that
the mean birth weight and the incidence of congenital anomalies are comparable to that of
spontaneous conceptions in fertile women or infertile women undergoing IVF treatment.
Status | Completed |
Enrollment | 17 |
Est. completion date | February 2013 |
Est. primary completion date | February 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 21 Years to 37 Years |
Eligibility |
Inclusion Criteria: 1. Females 21 to 37 years of age. 2. Normal serum follicle stimulating hormone (FSH) concentration <10 mIU/ml and estradiol (E2) concentration <70 pg/ml obtained on day #2 or 3 of the menstrual cycle. 3. BMI < 35. 4. No physical or gynecological abnormalities (including major uterine surgery) constituting a medical contraindication to embryo transfer and pregnancy including any known significant genetic disorders 5. Non-smoker for at least 3 months prior to study enrollment. 6. Normal antral follicle count (total = 10). Exclusion Criteria: 1. Greater than 1 previous miscarriage. 2. More than 1 previous failed IVF attempt. 3. Previous poor response to ovarian stimulation (peak E2 level <1,000 pg/ml or < 4 oocytes retrieved). 4. Presence of untreated hydrosalpinx. 5. Stage III or IV endometriosis. 6. Intent to have preimplantation genetic diagnosis (PGD) of embryos 7. Unwillingness to freeze or inseminate all eligible oocytes or embryos. 8. Male partner requiring surgical sperm retrieval (MESA or TESA). |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | The Center for Advanced Reproductive Services | Farmington | Connecticut |
Lead Sponsor | Collaborator |
---|---|
University of Connecticut Health Center | EMD Serono |
United States,
Antinori M, Licata E, Dani G, Cerusico F, Versaci C, Antinori S. Cryotop vitrification of human oocytes results in high survival rate and healthy deliveries. Reprod Biomed Online. 2007 Jan;14(1):72-9. — View Citation
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. Erratum in: Hum Reprod. 2004 Aug;19(8):1929. — View Citation
Cao YX, Xing Q, Li L, Cong L, Zhang ZG, Wei ZL, Zhou P. Comparison of survival and embryonic development in human oocytes cryopreserved by slow-freezing and vitrification. Fertil Steril. 2009 Oct;92(4):1306-11. doi: 10.1016/j.fertnstert.2008.08.069. Epub 2008 Oct 18. — View Citation
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. — View Citation
Chen C. Pregnancy after human oocyte cryopreservation. Lancet. 1986 Apr 19;1(8486):884-6. — View Citation
Chian RC, Huang JY, Tan SL, Lucena E, Saa A, Rojas A, Ruvalcaba Castellón LA, García Amador MI, Montoya Sarmiento JE. Obstetric and perinatal outcome in 200 infants conceived from vitrified oocytes. Reprod Biomed Online. 2008 May;16(5):608-10. — View Citation
Ciotti PM, Porcu E, Notarangelo L, Magrini O, Bazzocchi A, Venturoli S. Meiotic spindle recovery is faster in vitrification of human oocytes compared to slow freezing. Fertil Steril. 2009 Jun;91(6):2399-407. doi: 10.1016/j.fertnstert.2008.03.013. Epub 2008 Aug 3. — View Citation
Cobo A, Kuwayama M, Pérez S, Ruiz A, Pellicer A, Remohí J. Comparison of concomitant outcome achieved with fresh and cryopreserved donor oocytes vitrified by the Cryotop method. Fertil Steril. 2008 Jun;89(6):1657-64. Epub 2007 Sep 24. — View Citation
Fuku E, Xia L, Downey BR. Ultrastructural changes in bovine oocytes cryopreserved by vitrification. Cryobiology. 1995 Apr;32(2):139-56. — View Citation
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. — View Citation
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. — View Citation
Kuwayama M, Vajta G, Kato O, Leibo SP. Highly efficient vitrification method for cryopreservation of human oocytes. Reprod Biomed Online. 2005 Sep;11(3):300-8. — View Citation
Lucena E, Bernal DP, Lucena C, Rojas A, Moran A, Lucena A. Successful ongoing pregnancies after vitrification of oocytes. Fertil Steril. 2006 Jan;85(1):108-11. — View Citation
Noyes N, Porcu E, Borini A. Over 900 oocyte cryopreservation babies born with no apparent increase in congenital anomalies. Reprod Biomed Online. 2009 Jun;18(6):769-76. — View Citation
* Note: There are 14 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | oocyte survival | day of retrieval | No | |
Primary | fertilization | Day of retrieval | No | |
Primary | Embryo development | day 3 post retrieval | No | |
Secondary | Implantation | 3 weeks after transfer | No | |
Secondary | Clinical pregnancy | 2 weeks after transfer | No | |
Secondary | Miscarriage and live birth rates for those embryos derived from vitrified oocytes. | 9 months post transfer | No |
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