Oocyte Cryopreservation Comparing Fresh and Vitrified Sibling Oocytes
NCT ID: NCT00986687
Last Updated: 2015-12-03
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
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COMPLETED
17 participants
OBSERVATIONAL
2009-08-31
2013-02-28
Brief Summary
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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.
Detailed Description
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This is a pilot study to evaluate the outcomes of oocyte vitrification using the Cryotop method in women undergoing IVF, by simultaneously evaluating embryos derived from vitrified and fresh oocytes coming from the same stimulated cycle.
The primary outcome measures that will be tracked and tabulated are oocyte survival, fertilization and cleavage rate, and subsequent embryo development, compared between vitrified and fresh oocytes. Secondary outcomes are implantation, clinical pregnancy, miscarriage and live birth rates using embryos derived from the vitrified oocytes for transfer.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Vitrified oocytes
No interventions assigned to this group
Control oocytes
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
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
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).
21 Years
37 Years
FEMALE
Yes
Sponsors
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EMD Serono
INDUSTRY
UConn Health
OTHER
Responsible Party
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Claudio Benadiva
Laboratory Director and Director of the Preimplantation Genetics Diagnosis Program,
Principal Investigators
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Claudio Benadiva, MD, HCLD
Role: PRINCIPAL_INVESTIGATOR
The Center for Advanced Reproductive Services, P.C.
Locations
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The Center for Advanced Reproductive Services
Farmington, Connecticut, United States
Countries
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References
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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. doi: 10.1016/s1472-6483(10)60766-3.
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.
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):1306-1311. doi: 10.1016/j.fertnstert.2008.08.069. Epub 2008 Oct 18.
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.
Chen C. Pregnancy after human oocyte cryopreservation. Lancet. 1986 Apr 19;1(8486):884-6. doi: 10.1016/s0140-6736(86)90989-x.
Chian RC, Huang JY, Tan SL, Lucena E, Saa A, Rojas A, Ruvalcaba Castellon LA, Garcia 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. doi: 10.1016/s1472-6483(10)60471-3.
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.
Cobo A, Kuwayama M, Perez S, Ruiz A, Pellicer A, Remohi 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. doi: 10.1016/j.fertnstert.2007.05.050. Epub 2007 Sep 24.
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.
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. doi: 10.1016/s1472-6483(10)60837-1.
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.
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. doi: 10.1016/j.fertnstert.2005.09.013.
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. doi: 10.1016/s1472-6483(10)60025-9.
Other Identifiers
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29642
Identifier Type: -
Identifier Source: secondary_id
09-189-3
Identifier Type: -
Identifier Source: org_study_id