Performance Study of New Media for Vitrification of Human Oocytes
|ClinicalTrials.gov Identifier: NCT01481571|
Recruitment Status : Completed
First Posted : November 29, 2011
Last Update Posted : March 24, 2014
|Condition or disease||Intervention/treatment||Phase|
|Infertility||Device: Vitrification medium oocyte, warming medium oocyte and Rapid-i||Not Applicable|
A multi-center prospective sibling oocyte vitrification trial where, in the first phase, half of the patients' oocytes will be vitrified and warmed (experimental group). The remaining oocytes will not be vitrified and will serve as the control group. In the second phase all of the patients' oocytes will be vitrified and the embryo transfer will be performed in a following cycle. This simulates the situation of a normal cryopreservation embryo transfer. The study population consists of 20 women who will undergo a fresh IVF cycle during the study period. The primary objective in the first phase is to assess survival, fertilization and embryo development after oocyte vitrification/warming with the new media. The results will be compared with results from sibling oocytes which have not been vitrified. Secondary objectives are to assess the clinical results such as implantation, miscarriage and pregnancy rate as well as delivery rate and neonatal outcome.
The primary objective in the second phase is to assess the delivery rate after oocyte vitrification/warming with the new media. Secondary objectives are to assess survival, fertilization, embryo development, utilization rate, pregnancy rate and neonatal outcome on the previously vitrified and warmed oocytes. The results will be compared with results from a control group of patients, treated at the same clinics within the same time period, using the same inclusion and exclusion criteria. All patients who undergo embryo transfer will have a serum beta-hCG test conducted 14 days after oocyte retrieval. If positive, repeat beta-hCG testing will be conducted 2-4 days later. If appropriate, a pregnancy ultrasound will be conducted between 6-8 weeks gestation (menstrual age) to record gestational sac(s) and fetal heart beat. The delivery outcome will also be recorded. For patients with an unsuccessful treatment, there will be a follow-up period of 6 months after study completion. From this follow-up, data from frozen cycles, i.e. from embryos after oocyte vitrification, can be evaluated as well.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||17 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Performance Study of New Media for Vitrification of Human Oocytes|
|Study Start Date :||January 2012|
|Actual Primary Completion Date :||August 2012|
|Actual Study Completion Date :||September 2012|
Experimental: Vitrification media and device
Vitrification medium oocyte, warming medium oocyte and Rapid-i
Device: Vitrification medium oocyte, warming medium oocyte and Rapid-i
Media and device for vitrification of human oocytes
- Embryo development after oocyte vitrification/warming. [ Time Frame: 5 days after oocyte retrieval ]Embryo development, as number of good quality blastocysts, after oocyte vitrification and warming.
- Implantation rate of previously vitrified/warmed oocytes. [ Time Frame: 4 weeks after embryo transfer ]Number of embryos implanted. Expressed as a percentage of number transferred.
- Ongoing pregnancy rate [ Time Frame: 3 months after embryo transfer ]Number of ongoing pregnancies at 3months. Expressed as a percentage of patients undergoing embryo transfer.
- Live birth [ Time Frame: 9 months after embryo transfer ]Number of lives births results from embryos transferred.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01481571
|United States, Texas|
|The DFW Fertility Associates, Reproductive Endocrinology and Infertility, Dallas Fertility Centre|
|Dallas, Texas, United States, 75231|
|Frisco, Texas, United States, 75034|
|Principal Investigator:||Marius Meintjes, Dr|