Oocyte Cryopreservation Comparing Fresh and Vitrified Sibling Oocytes

NCT00986687 | Completed

• 2 other identifiers: 09-189-329642
• Study Type: observational
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Infertility

Keywords

Oocyte cryopreservation; vitrification

Outcome Measures

Primary Outcomes (3)

• oocyte survival

  day of retrieval

• fertilization

  Day of retrieval

• Embryo development

  day 3 post retrieval

Secondary Outcomes (3)

• Implantation

  3 weeks after transfer

• Clinical pregnancy

  2 weeks after transfer

• Miscarriage and live birth rates for those embryos derived from vitrified oocytes.

  9 months post transfer

Study Arms (2)

Vitrified oocytes

Control oocytes

Eligibility Criteria

• Age: 21 Years - 37 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The Center for Advanced Reproductive Services patient population

You may qualify if:

• Females 21 to 37 years of age.
• 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.
• BMI \< 35.
• No physical or gynecological abnormalities (including major uterine surgery) constituting a medical contraindication to embryo transfer and pregnancy including any known significant genetic disorders
• Non-smoker for at least 3 months prior to study enrollment.
• Normal antral follicle count (total ≥ 10).

You may not qualify if:

• Greater than 1 previous miscarriage.
• More than 1 previous failed IVF attempt.
• Previous poor response to ovarian stimulation (peak E2 level \<1,000 pg/ml or \< 4 oocytes retrieved).
• Presence of untreated hydrosalpinx.
• Stage III or IV endometriosis.
• Intent to have preimplantation genetic diagnosis (PGD) of embryos
• Unwillingness to freeze or inseminate all eligible oocytes or embryos.
• Male partner requiring surgical sperm retrieval (MESA or TESA).

Sponsors & Collaborators

• UConn Health: lead
• EMD Serono: collaborator

Study Sites (1)

The Center for Advanced Reproductive Services

Farmington, Connecticut, 06030-6224, United States

Location

Related Publications (14)

• 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.

  PMID: 17207335 BACKGROUND

• 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.

  PMID: 12773454 BACKGROUND

• 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.

  PMID: 18930218 BACKGROUND

• 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.

  PMID: 2250252 BACKGROUND

• Chen C. Pregnancy after human oocyte cryopreservation. Lancet. 1986 Apr 19;1(8486):884-6. doi: 10.1016/s0140-6736(86)90989-x.

  PMID: 2870356 BACKGROUND

• 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.

  PMID: 18492361 BACKGROUND

• 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.

  PMID: 18675965 BACKGROUND

• 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.

  PMID: 17889865 BACKGROUND

• 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.

  PMID: 7743816 BACKGROUND

• 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.

  PMID: 10428163 BACKGROUND

• 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.

  PMID: 16176668 BACKGROUND

• 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.

  PMID: 10601099 BACKGROUND

• 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.

  PMID: 16412739 BACKGROUND

• 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.

  PMID: 19490780 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Embryos

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Claudio Benadiva, MD, HCLD

  The Center for Advanced Reproductive Services, P.C.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Laboratory Director and Director of the Preimplantation Genetics Diagnosis Program,

Study Record Dates

• First Submitted: September 29, 2009
• First Posted: September 30, 2009
• Study Start: August 1, 2009
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: December 3, 2015

Record last verified: 2015-12

Locations

US (1)