Ignite Creation Date:
2025-12-24 @ 9:06 PM
Ignite Modification Date:
2025-12-30 @ 2:15 AM
Study NCT ID:
NCT01219504
Status:
COMPLETED
Last Update Posted:
2013-01-23
First Post:
2010-10-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Impact of Embryo Biopsy on the Reproductive Potential of Embryos Undergoing In Vitro Fertilization (IVF)
Sponsor:
Reproductive Medicine Associates of New Jersey
Organization:
Study Overview
Official Title:
Evaluation of the Impact of Embryo Biopsy on the Reproductive Potential of Embryos Undergoing IVF
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:
To assess the impact of embryo biopsy on the reproductive potential of human embryos.
Detailed Description:
This study will recruit patients from the NY/NJ/CT/eastern PA area only.
All patients will undergo an in vitro fertilization (IVF) cycle with hormonal stimulation and an egg retrieval procedure as deemed appropriate for their diagnosis. Following biopsy, the embryos will be transferred. There will be no delay in the time of transfer as no cells will be analyzed prior to transfer.
On day 3 or day 5 of embryo development, all patients will undergo a two (2) embryo transfer. The embryos selected for transfer will be the 2 morphologically best of the embryo cohort. Once selected for transfer, the embryos will be randomized so that one will be biopsied and the other will be transferred without undergoing biopsy. The embryo randomized to biopsy will have a single cell biopsied.
Following delivery, buccal swabs will be collected from infants.
All patients will undergo an in vitro fertilization (IVF) cycle with hormonal stimulation and an egg retrieval procedure as deemed appropriate for their diagnosis. Following biopsy, the embryos will be transferred. There will be no delay in the time of transfer as no cells will be analyzed prior to transfer.
On day 3 or day 5 of embryo development, all patients will undergo a two (2) embryo transfer. The embryos selected for transfer will be the 2 morphologically best of the embryo cohort. Once selected for transfer, the embryos will be randomized so that one will be biopsied and the other will be transferred without undergoing biopsy. The embryo randomized to biopsy will have a single cell biopsied.
Following delivery, buccal swabs will be collected from infants.
Study Oversight
Has Oversight DMC:
False
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?: