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

Not Applicable

Recruiting

• Conditions: Infertility; IVF; Artificial Oocyte Activation
• Interventions: Other: calcium ionophore

• Registration Number: NCT05722067
• Lead Sponsor: Chang Gung Memorial Hospital

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-11-20
• Study Start: 2023-01-01
• Study First Submitted QC: 2023-02-08
• Study First Posted: 2023-02-10
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-19
• Last Update Posted: 2025-02-20
• Primary Completion: 2025-03-31
• Study Completion: 2025-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
oocytes treated with calcium ionophore	calcium ionophore	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.

Primary Outcome Measures

Name	Time	Method
fertilization rate	Day 1	The normal fertilization rate will defined as the number of zygotes with 2PN and 2PB per the total number of mature oocytes

Secondary Outcome Measures

Name	Time	Method
pregnancy outcome	1 year	pregnancy rates, abortion rate, live birth rates,congenital anomaly rate
blastocyst formation rate	Day 5	NO. of blastocysts per 2PN zygotes
top-quality blastocyst formation rate	Day 5	No. of 3AA, 4AA, 5AA or 6AA blastocysts / 2PN zygotes

Trial Locations

Locations (1)

Chang Gung Memorial Hospital; 🇨🇳 Kaohsiung, Taiwan