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

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

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05722067

Acronym

GM508 in IVF

Enrollment

Registered

2023-02-10

Start date

2023-01-01

Completion date

2025-06-30

Last updated

2026-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Artificial Oocyte Activation, Infertility, IVF

Keywords

artificial oocyte activation, calcium ionophore, ivf, poor responder

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).

Interventions

OTHERcalcium 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 50 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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
pregnancy outcome	1 year	pregnancy rates, abortion rate, live birth rates,congenital anomaly rate

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 21, 2026