Infertility Clinical Trial
Official title:
Performance Study of New Media for Vitrification of Human Oocytes
Verified date | February 2014 |
Source | Vitrolife |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
The purpose of this study is to evaluate safety and performance of Vitrolife´s new oocyte vitrification/warming media and the vitrification device Rapid-i™, when using vitrification as a cryopreservation method for human oocytes.
Status | Completed |
Enrollment | 17 |
Est. completion date | September 2012 |
Est. primary completion date | August 2012 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 37 Years |
Eligibility |
Inclusion Criteria: - Couple agreed to participate in study and has signed the Informed Consent Document before any study-related activities - Patient age (female): 18-37 years (including oocyte donors) - BMI 18-27 kg/m2 (female) - 2 ovaries, normal uterine cavity (female) - Day 3 FSH = 10mIU, E2 <80 pg/mL and an AFC =12 (both ovaries, 3 mm or greater) (female) - AMH >1 (female) - Ejaculatory sperm (male) - ICSI fertilization - Long standard stimulation protocol - English speaking Exclusion Criteria: - Previous participation in the study - =2 previous failed IVF cycles - Endometrioma - Presence of a hydrosalpinx - History of recurrent miscarriage (defined as =2 clinical recognized SABs) - Not willing to have ICSI performed - Cycle length >6 weeks [a diagnosis of PCOS will not exclude from the study unless typical cycle length is greater than 6 weeks; this criteria would exclude hypothalamic-hypogonadotropic patients] |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | The DFW Fertility Associates, Reproductive Endocrinology and Infertility, Dallas Fertility Centre | Dallas | Texas |
United States | Frisco IVF | Frisco | Texas |
Lead Sponsor | Collaborator |
---|---|
Vitrolife |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Embryo development after oocyte vitrification/warming. | Embryo development, as number of good quality blastocysts, after oocyte vitrification and warming. | 5 days after oocyte retrieval | No |
Secondary | Implantation rate of previously vitrified/warmed oocytes. | Number of embryos implanted. Expressed as a percentage of number transferred. | 4 weeks after embryo transfer | No |
Secondary | Ongoing pregnancy rate | Number of ongoing pregnancies at 3months. Expressed as a percentage of patients undergoing embryo transfer. | 3 months after embryo transfer | No |
Secondary | Live birth | Number of lives births results from embryos transferred. | 9 months after embryo transfer | No |
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