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
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Infertility
• IVF

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