Results Following the Vitrification of Human Oocytes Using 2 Methodologies

NCT ID: NCT01033474

Last Updated: 2011-07-22

Basic Information

• Recruitment Status: WITHDRAWN
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-12-31
• Study Completion Date: 2011-07-31

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.

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.

Conditions

Infertility

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

donor eggs

No interventions assigned to this group

infertile patients

No interventions assigned to this group

Eligibility 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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Northwest Center for Reproductive Sciences

OTHER

Sponsor Role: lead

Responsible Party

Pranor and NW Center for Reproductive Sciences

Locations

Laboratorio de Reproducción Asistida

Lima, , Peru

Countries

Peru

Other Identifiers

555-2009

Identifier Type: -

Identifier Source: org_study_id