NCT01223118

Evaluation of the Impact of Vitrification on Oocytes

Evaluation of the Impact of Vitrification on the Reproductive Performance and Potential of Human Oocytes

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Reproductive Medicine Associates of New Jersey · Academic / Other
• Sex: All
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to determine the rate of cryosurvival of mature oocytes following vitrification, and to then compare the reproductive potential of vitrified oocytes relative to those which have not been cryopreserved.

Detailed description

This study will recruit patients from the NY/NJ/CT/eastern PA area only. Cryopreservation of human oocytes has a great potential to preserve or extend fertility in the face of disease whose treatment would result in a loss of ovarian function. (malignancy, severe autoimmune disease, etc.). It would also provide a means of quarantining oocytes to be used in oocyte donation to provide the lowest possible risk of infection. There are two methods for storage of oocytes: slow freezing or vitrification. Slow freezing is the conventional method and has been successfully used for embryos since 1983 and more recently for oocytes. Recent reports indicate that vitrification may be more successful than slow freezing. However, the technique has not been rigorously validated to date. The aim of this study is to determine the rate of cryosurvival of mature oocytes following vitrification, and to then compare the reproductive potential of vitrified oocytes relative to those which have not been cryopreserved. Patients will undergo ovarian stimulation for in vitro fertilization (IVF) according to the protocol recommended by their primary doctor. After retrieval, mature oocytes will be divided in half. One half will undergo vitrification, immediate thaw and intracytoplasmic sperm injection (ICSI). The other half will undergo just ICSI. All embryos will then develop on identical culture until day 3 or day 5. Prior to transfer, the best embryo from each group will undergo biopsy for genetic fingerprinting. The patient will have a 2 embryo transfer (one from each group). All extra embryos will be biopsied for pre-implantation genetic diagnosis (PGD) prior to being cryopreserved. If the patient becomes pregnant, we will follow up with an additional blood draw at approximately 9 weeks gestation and buccal swabs after the delivery of the infant(s).

Conditions

• Fertilization

Interventions

Type	Name	Description
PROCEDURE	Vitrification and PGD	Half of the oocytes retrieved from each patient will undergo vitrification, immediate thaw and insemination. All embryos will undergo biopsy for PGD prior to transfer.

Timeline

• Start date: 2010-08-01
• Primary completion: 2012-07-01
• Completion: 2012-07-01
• First posted: 2010-10-18
• Last updated: 2013-01-23

Locations

2 sites across 1 country: United States