Viewing Study NCT01506089



Ignite Creation Date: 2024-05-06 @ 12:10 AM
Last Modification Date: 2024-10-26 @ 10:45 AM
Study NCT ID: NCT01506089
Status: COMPLETED
Last Update Posted: 2015-03-26
First Post: 2012-01-03

Brief Title: Optimizing the Temperature for Embryo Culture in In Vitro Fertilization
Sponsor: Reproductive Medicine Associates of New Jersey
Organization: Reproductive Medicine Associates of New Jersey

Study Overview

Official Title: Optimizing the Temperature for Embryo Culture in In Vitro Fertilization A Randomized Controlled Trial
Status: COMPLETED
Status Verified Date: 2015-03
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: Many human and animal studies over the past 40 years have revealed that ovaries and Fallopian tubes have a lower temperature than core body temperature especially around the time of ovulation and early embryo development Whether average core body temperature 37 degrees Celsius is ideal temperature for culture has not been prospectively evaluated The purpose of this study is to determine whether lowering the incubator temperature by 1 degree Celsius will result in meaningful improvements in embryo development and pregnancy rates

Patients participating in this study will undergo routine in vitro fertilization IVF stimulation Following egg retrieval patients with at least 8 mature eggs will have those eggs divided randomly into two groups Both groups will then under ICSI intra-cytoplasmic sperm injection to fertilize the eggs The groups will randomly be assigned to control or study condition The control condition group will be cultured at 37 degrees Celsius the current standard of care The study group will be cultured at 36 degrees Celsius All other culture conditions will be kept identical and embryos will be assessed on day 3 and day 5 of development

On day 5 all well-developed blastocysts will undergo biopsy for Comprehensive Chromosomal Screening CCS which will evaluate the chromosomal normalcy of the embryo Patients will undergo transfer on the morning of day 6 and the highest quality chromosomally normal embryo from each group the 36 degree cultured embryos and the 37 degree cultured embryos will be transferred If only 1 embryo is available for transfer the patient will have a single embryo transfer

All embryos available for cryopreservation will undergo biopsy for CCS before being frozen Some arrested embryos from each temperature group will also undergo genetic analysis to evaluate chromosomal normalcy or mosaicism

The female patient will undergo a blood draw at 9 weeks gestation and buccal swabs will be obtained from the infants after birth
Detailed Description: None

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