Performance Study of New Media for Vitrification of Human Oocytes

Completed · Not applicable

Conditions studied: Infertility

In brief

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.

Key facts

Study ID

NCT01481571

Run by

Vitrolife

People needed

17

Starts

2012-01-01

Expected to finish

2012-09-01

Last updated by the study team

2014-03-24

Who can join

Age: 18 and older, up to 37. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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]

Where it is running

• The DFW Fertility Associates, Reproductive Endocrinology and Infertility, Dallas Fertility Centre — Dallas, Texas, United States
• Frisco IVF — Frisco, Texas, United States

Full record on ClinicalTrials.gov

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