We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Results Following the Vitrification of Human Oocytes Using 2 Methodologies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01033474
Recruitment Status : Withdrawn (NW Center for Reproductive Sciences was sold and is no longer open)
First Posted : December 16, 2009
Last Update Posted : July 22, 2011
Sponsor:
Information provided by:
Northwest Center for Reproductive Sciences

Brief Summary:

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.

Condition or disease
Infertility

Detailed Description:

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.

Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Embryonic Developmental Rates and Pregnancies Following the Vitrification of Human Oocytes Using Two Methodologies.
Study Start Date : December 2009
Estimated Primary Completion Date : September 2010
Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Infertility
U.S. FDA Resources

Group/Cohort
donor eggs
infertile patients



Secondary Outcome Measures :
  1. Pregnancy rate [ Time Frame: 12 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   25 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
We will use infertile patients that need donor oocytes
Criteria

Inclusion Criteria:

  • Must be healthy and pass testing as per clinic standards

Exclusion Criteria:

  • Are over the age or cannot carry a pregnancy safely

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01033474


Locations
Peru
Laboratorio de Reproducción Asistida
Lima, Peru
Sponsors and Collaborators
Northwest Center for Reproductive Sciences

Responsible Party: Klaus Wiemer PhD, Pranor and NW Center for Reproductive Sciences
ClinicalTrials.gov Identifier: NCT01033474     History of Changes
Other Study ID Numbers: 555-2009
First Posted: December 16, 2009    Key Record Dates
Last Update Posted: July 22, 2011
Last Verified: July 2011

Keywords provided by Northwest Center for Reproductive Sciences:
Infertile Patients

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