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.

Study Overview

• Status: Withdrawn
• Conditions: 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
• Enrollment (Anticipated): 40

Contacts and Locations

Study Locations

• Peru
  • Lima, Peru
    • Laboratorio de Reproducción Asistida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

We will use infertile patients that need donor oocytes

Description

Inclusion Criteria:

• Must be healthy and pass testing as per clinic standards

Exclusion Criteria:

• Are over the age or cannot carry a pregnancy safely

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
donor eggs
infertile patients

What is the study measuring?

Secondary Outcome Measures

Outcome Measure	Time Frame
Pregnancy rate	12 weeks

Collaborators and Investigators

• Sponsor: Northwest Center for Reproductive Sciences

Study record dates

Study Major Dates

• Study Start: December 1, 2009
• Primary Completion (Anticipated): September 1, 2010
• Study Completion (Actual): July 1, 2011

Study Registration Dates

• First Submitted: December 14, 2009
• First Submitted That Met QC Criteria: December 15, 2009
• First Posted (Estimate): December 16, 2009

Study Record Updates

• Last Update Posted (Estimate): July 22, 2011
• Last Update Submitted That Met QC Criteria: July 21, 2011
• Last Verified: July 1, 2011

More Information

Terms related to this study

• Keywords: Infertile Patients
• Additional Relevant MeSH Terms: Infertility
• Other Study ID Numbers: 555-2009