Improvement of Fertilization Rate and Embryo Quality by Treating Calcium Ionophore in IVF Patients: a Sibling Oocyte Control Study (GM508 in IVF)

Chang Gung Medical Foundation

Status: Enrolling

Conditions: Infertility; IVF; Artificial Oocyte Activation

Treatments: Other: calcium ionophore

Study type: Interventional

Funder types: Other

Identifiers

NCT05722067

202200969A3

Details and patient eligibility

About

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).

Enrollment: 200 estimated patients

Sex: Female

Ages: 20 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Low fertilization rate in previous IVF cycle (<30%), or
• Poor embryo developmental problems in previous IVF cycle, or
• Diminished ovarian reserve (AMH<1.2 or AFC<5) and/or more than 40 y/o.

Exclusion criteria

• Without or just one oocyte picked up

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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200 participants in 2 patient groups

oocytes treated with calcium ionophore

Experimental group

Description:

Oocytes treated with a ready-to-use ionophore compound (GM508 CultActive, Gynemed) within 15 min after ICSI (or 18 min in IVF). After 15 min of incubation in GM508 CultActive and a thorough washing process, the oocytes subjected to AOA will transfer to the same time-lapse culture dish with the controlled sibling group.

Treatment:

Other: calcium ionophore

oocytes undergo routine IVF/ICSI protocol

No Intervention group

Description:

Untreated control oocytes will immediately place into the time-lapse imaging system, and the culture protocol was routine.