Clinical trial NCT01033474: Results Following the Vitrification of Human Oocytes Using 2 Methodologies
Official title: Embryonic Developmental Rates and Pregnancies Following the Vitrification of Human Oocytes Using Two Methodologies.
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Infertility
Keywords: Infertile Patients
Lead sponsor: Northwest Center for Reproductive Sciences
Sponsor class: OTHER
First posted: 2009-12-16
Enrollment: 40
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We will use infertile patients that need donor oocytes

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.

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

Primary outcomes:
Secondary outcomes:
measure: Pregnancy rate
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Lima
country: Peru
facility: Laboratorio de Reproducción Asistida
Study officials:
References: