NCT00602966

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2006

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2006

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

January 15, 2008

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 28, 2008

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

October 28, 2011

Status Verified

October 1, 2011

Enrollment Period

3.3 years

First QC Date

January 15, 2008

Last Update Submit

October 26, 2011

Conditions

Infertility

Keywords

Oocyte cryopreservationslow freezevitrification

Outcome Measures

Primary Outcomes (1)

  • Oocyte survival

    When patient returns for thaw cycle

Secondary Outcomes (1)

  • Implantation rate

    2 weeks after transfer of thawed oocyte

Study Arms (2)

Slow Freeze

Vitrification

Eligibility Criteria

Age21 Years - 36 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

The Center for Advanced Reproductive Services patient population

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Center for Advanced Reproductive Services

Farmington, Connecticut, 06030-6224, United States

Location

Related Publications (11)

  • 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: 12773454BACKGROUND

  • 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: 2250252BACKGROUND

  • 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: 7743816BACKGROUND

  • 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: 10428163BACKGROUND

  • 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: 10601099BACKGROUND

  • 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.

    PMID: 9341619BACKGROUND

  • 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.

    PMID: 11155951BACKGROUND

  • 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.

    PMID: 3969158BACKGROUND

  • 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.

    PMID: 9687313BACKGROUND

  • 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.

    PMID: 9917351BACKGROUND

  • 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.

    PMID: 12061843BACKGROUND

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Claudio Benadiva, MD, HCLD

    The Center for Advanced Reproductive Services, P.C.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
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

January 15, 2008

First Posted

January 28, 2008

Study Start

July 1, 2006

Primary Completion

October 1, 2009

Study Completion

May 1, 2010

Last Updated

October 28, 2011

Record last verified: 2011-10

Locations

US(1)