Viewing Study NCT01223118



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Last Modification Date: 2024-10-26 @ 10:26 AM
Study NCT ID: NCT01223118
Status: COMPLETED
Last Update Posted: 2013-01-23
First Post: 2010-10-08

Brief Title: Evaluation of the Impact of Vitrification on Oocytes
Sponsor: Reproductive Medicine Associates of New Jersey
Organization: Reproductive Medicine Associates of New Jersey

Study Overview

Official Title: Evaluation of the Impact of Vitrification on the Reproductive Performance and Potential of Human Oocytes
Status: COMPLETED
Status Verified Date: 2013-01
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief 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 NYNJCTeastern 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 infants

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None