Oocyte Cryopreservation: Slow Cooling Versus Vitrification Techniques on Oocyte Survival

This study has been completed.
Sponsor:
Collaborator:
EMD Serono
Information provided by (Responsible Party):
Claudio Benadiva, University of Connecticut Health Center
ClinicalTrials.gov Identifier:
NCT00602966
First received: January 15, 2008
Last updated: October 26, 2011
Last verified: October 2011
  Purpose

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.


Condition
Infertility

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Oocyte Cryopreservation: Comparison of Slow Cooling Versus Vitrification Techniques on Oocyte Survival, Fertilization, and Embryo Development

Resource links provided by NLM:


Further study details as provided by University of Connecticut Health Center:

Primary Outcome Measures:
  • Oocyte survival [ Time Frame: When patient returns for thaw cycle ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Implantation rate [ Time Frame: 2 weeks after transfer of thawed oocyte ] [ Designated as safety issue: No ]

Enrollment: 14
Study Start Date: July 2006
Study Completion Date: May 2010
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
Slow Freeze
Vitrification

Detailed Description:

Cryopreservation of oocytes is desirable because it: 1) would allow infertility patients to store excess oocytes instead of embryos, eliminating some of the ethical and religious concerns that accompany embryo storage; 2) permit storage of donor oocytes to avoid donor-recipient synchronization difficulties; and 3) can help women who may face sterilization due to chemotherapy or radiation. Oocyte cryopreservation is therefore gaining in popularity as an option for infertility treatment as well as fertility preservation.

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).

  Eligibility

Ages Eligible for Study:   21 Years to 36 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

The Center for Advanced Reproductive Services patient population

Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00602966

Locations
United States, Connecticut
The Center for Advanced Reproductive Services
Farmington, Connecticut, United States, 06030-6224
Sponsors and Collaborators
University of Connecticut Health Center
EMD Serono
Investigators
Principal Investigator: Claudio Benadiva, MD, HCLD The Center for Advanced Reproductive Services, P.C.
  More Information

Publications:

Responsible Party: Claudio Benadiva, Laboratory Director and Director of the Preimplantation Genetics Diagnosis Program,, University of Connecticut Health Center
ClinicalTrials.gov Identifier: NCT00602966     History of Changes
Other Study ID Numbers: 06-336-2, 26525
Study First Received: January 15, 2008
Last Updated: October 26, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Connecticut Health Center:
Oocyte cryopreservation
slow freeze
vitrification

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on September 18, 2014