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This study has been withdrawn prior to enrollment.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
  Purpose

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
Infertility

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Embryonic Developmental Rates and Pregnancies Following the Vitrification of Human Oocytes Using Two Methodologies.

Resource links provided by NLM:


Further study details as provided by Northwest Center for Reproductive Sciences:

Secondary Outcome Measures:
  • Pregnancy rate [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: December 2009
Study Completion Date: July 2011
Estimated Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
donor eggs
infertile patients

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.
  Eligibility

Ages Eligible for Study:   25 Years to 55 Years
Genders 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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01033474

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

No publications provided

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
Study First Received: December 14, 2009
Last Updated: July 21, 2011
Health Authority: Peru: Ethics Committee

Keywords provided by Northwest Center for Reproductive Sciences:
Infertile Patients

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

ClinicalTrials.gov processed this record on July 26, 2014