Performance Study of New Media for Vitrification of Human Oocytes

Launched by VITROLIFE · Nov 28, 2011

Keywords

ClinConnect Summary

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 pha...

Gender

FEMALE

Eligibility criteria

• 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 \[a diagnosis of PCOS will not exclude from the study unless typical cycle length is greater than 6 weeks; this criteria would exclude hypothalamic-hypogonadotropic patients\]

Trial Officials