Results Following the Vitrification of Human Oocytes Using 2 Methodologies

This study has been withdrawn prior to enrollment.
(NW Center for Reproductive Sciences was sold and is no longer open)
Sponsor:
Information provided by:
Northwest Center for Reproductive Sciences
ClinicalTrials.gov Identifier:
NCT01033474
First received: December 14, 2009
Last updated: July 21, 2011
Last verified: July 2011

December 14, 2009
July 21, 2011
December 2009
September 2010   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT01033474 on ClinicalTrials.gov Archive Site
Pregnancy rate [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Same as current
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Results Following the Vitrification of Human Oocytes Using 2 Methodologies
Embryonic Developmental Rates and Pregnancies Following the Vitrification of Human Oocytes Using Two Methodologies.

The investigators are going to compare embryo developmental rates of human eggs following freezing in two different freezing methods. The investigators are going to compare the pregnancy rates following transfer to patients as well.

Null Hypothesis: The type of vitrification methodology used will not have an impact on the following:

  • Survival rates
  • Embryonic developmental rates
  • Pregnancy and implantation rates.

Randomization of Oocytes: Oocytes will be denuded approximately 1-2 hours post retrieval and graded for maturity. Only the Metaphase II oocyte will be vitrified. Half of the oocytes within each donor will be randomized to the following treatments.

  1. Frozen using an open system using a metal grid to hold the oocyte. Three to five oocytes will be frozen on the metal grid using a minute amount (< 2-3 µls) of cryoprotectant. A top is put over the metal grid to protect the oocytes. This system has proven to be successful in limited cases in Peru. This is an open system of vitrification where the oocytes are directly plunged into liquid nitrogen. This will serve as the control.
  2. Frozen in closed straws using a methodology developed by Jim Stachecki. Three to five oocytes will be frozen in ¼ cc straws. This is very similar to the method used to successfully vitrify blastocysts. This will be the experimental treatment.

Null Hypothesis: The type of vitrification methodology used will not have an impact on the following:

  • Survival rates
  • Embryonic developmental rates
  • Pregnancy and implantation rates. Measured Outcomes The effect of vitrification technique will be measured using the appropriate statistical analysis on the following parameters.

    1. Survival rates following thawing.
    2. Effect of vitrification technique on how oocytes react to ICSI. The parameters have been previously defined at NCRS.
    3. Normal fertilization rates, abnormal fertilization rates and rates of degeneration following ICSI.
    4. Embryonic development rates. Embryos will be cultured until Day 5/6 and rate as well as quality of blastocyst will be noted.
    5. Pregnancy and implantation rates following replacement in endometrial prepared recipients.
Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample

We will use infertile patients that need donor oocytes

Infertility
Not Provided
  • donor eggs
  • infertile patients
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
40
July 2011
September 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Must be healthy and pass testing as per clinic standards

Exclusion Criteria:

  • Are over the age or cannot carry a pregnancy safely
Female
25 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Peru
 
NCT01033474
555-2009
Yes
Klaus Wiemer PhD, Pranor and NW Center for Reproductive Sciences
Northwest Center for Reproductive Sciences
Not Provided
Not Provided
Northwest Center for Reproductive Sciences
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP