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NCT05722067 Clinical Trial

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

Infertility Clinical Trial

— GM508 in IVF  

Official title:
Improved the Low Fertilization Rates and Increased the High-quality Embryogenesis by Treatment With Calcium Ionophore GM508 CultActive Optimized Medium in Vitro Fertilization (IVF) Patients

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05722067
Other study ID # 202200969A3
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 1, 2023
Est. completion date December 31, 2024

Study information
Verified date February 2024
Source Chang Gung Memorial Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).

Recruitment information / eligibility
Status Recruiting
Enrollment 200
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 50 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Other:
• calcium ionophore
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.

Locations
Country Name City State
Taiwan Chang Gung Memorial Hospital Kaohsiung

Sponsors (1)
Lead Sponsor Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome
Type Measure Description Time frame Safety issue
Primary fertilization rate The normal fertilization rate will defined as the number of zygotes with 2PN and 2PB per the total number of mature oocytes Day 1
Secondary blastocyst formation rate NO. of blastocysts per 2PN zygotes Day 5
Secondary top-quality blastocyst formation rate No. of 3AA, 4AA, 5AA or 6AA blastocysts / 2PN zygotes Day 5
Secondary pregnancy outcome pregnancy rates, abortion rate, live birth rates,congenital anomaly rate 1 year
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