Status:
COMPLETED
Performance Study of New Media for Vitrification of Human Oocytes
Lead Sponsor:
Vitrolife
Conditions:
Infertility
Eligibility:
FEMALE
18-37 years
Phase:
NA
Brief Summary
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 cryopreservat...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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 \[a diagnosis of PCOS will not exclude from the study unless typical cycle length is greater than 6 weeks; this criteria would exclude hypothalamic-hypogonadotropic patients\]
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2012
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT01481571
Start Date
January 1 2012
End Date
September 1 2012
Last Update
March 24 2014
Active Locations (2)
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1
The DFW Fertility Associates, Reproductive Endocrinology and Infertility, Dallas Fertility Centre
Dallas, Texas, United States, 75231
2
Frisco IVF
Frisco, Texas, United States, 75034