Results Following the Vitrification of Human Oocytes Using 2 Methodologies

Infertility Clinical Trial

Official title:

Embryonic Developmental Rates and Pregnancies Following the Vitrification of Human Oocytes Using Two Methodologies.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01033474
• Other study ID #: 555-2009
• Status: Withdrawn
• Phase: N/A
• First received: December 14, 2009
• Last updated: July 21, 2011
• Start date: December 2009
• Est. completion date: July 2011

Study information

• Verified date: July 2011
• Source: Northwest Center for Reproductive Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Peru: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 40
• Est. completion date: July 2011
• Est. primary completion date: September 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years to 55 Years

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Infertility

Locations

Country	Name	City	State
Peru	Laboratorio de Reproducción Asistida	Lima

Sponsors (1)

Lead Sponsor	Collaborator
Northwest Center for Reproductive Sciences

Country where clinical trial is conducted

Peru, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Secondary	Pregnancy rate		12 weeks	No