GM508 CultActive is a bicarbonate buffered reagent and ready-to-use designed to investigate oocytes of patients with failed fertilization after previous Intracytoplasmatic Sperm Injection cycles. The investigators hypothesize that GM508 CultActive will improve the fertilization rate and embryo development of such IVF patients (a history of poor fertilization, a history of poor embryo quality, and over 40 years old expected challenging to conceive).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
200
The intervention group will be treated with a ready-to-use ionophore medium (GM508 CultActive, Gynemed) within 15 min after ICSI (or 18 min in IVF) based on the situation of sperm. After 15 min of incubation in GM508 CultActive and a thorough washing process, the oocytes will be cultured in the same protocol as the control group.
Chang Gung Memorial Hospital
Kaohsiung City, Taiwan
RECRUITINGfertilization rate
The normal fertilization rate will defined as the number of zygotes with 2PN and 2PB per the total number of mature oocytes
Time frame: Day 1
blastocyst formation rate
NO. of blastocysts per 2PN zygotes
Time frame: Day 5
top-quality blastocyst formation rate
No. of 3AA, 4AA, 5AA or 6AA blastocysts / 2PN zygotes
Time frame: Day 5
pregnancy outcome
pregnancy rates, abortion rate, live birth rates,congenital anomaly rate
Time frame: 1 year
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