CClinicalTrials.gg
CompletedNCT05722067GM508 in IVFUpdated Mar 20, 2026

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

An interventional study of calcium ionophore in IVF, Infertility and Artificial Oocyte Activation, sponsored by Chang Gung Memorial Hospital. Completed at 1 site in Taiwan. Open to female participants aged 20 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-03-20.

Sponsored by Chang Gung Memorial Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
68
Allocation
Randomized
Ages
20 Years to 50 Years
Sex
Female
01

Study 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).

02

Conditions studied

  • IVF
  • Infertility
  • Artificial Oocyte Activation

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Keywords

  • artificial oocyte activation
  • calcium ionophore
  • ivf
  • poor responder
03

In context

Infertility

2,506 studies on the registry are indexed under Infertility; 407 are open to participants now.

This study's enrollment of 68 is below the median of 120 across 1,698 interventional studies indexed under Infertility.

Browse Infertility studies →

Lead sponsor

Chang Gung Memorial Hospital is the lead sponsor of 1,064 studies on the registry; 235 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 50 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Without or just one oocyte picked up
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
68 participants (actual)

Study arms

  • Experimental
    oocytes treated with 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.

    Other: calcium ionophore

  • No intervention
    oocytes undergo routine IVF/ICSI protocol

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

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.

    Also known as: GM508 CultActive

06

What researchers measure

Primary outcomes

  1. fertilization rate

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

    Time frame: Day 1

Secondary outcomes

  1. blastocyst formation rate

    NO. of blastocysts per 2PN zygotes

    Time frame: Day 5

  2. top-quality blastocyst formation rate

    No. of 3AA, 4AA, 5AA or 6AA blastocysts / 2PN zygotes

    Time frame: Day 5

  3. pregnancy outcome

    pregnancy rates, abortion rate, live birth rates,congenital anomaly rate

    Time frame: 1 year

07

Study locations

1 site
  • Chang Gung Memorial Hospital
    Kaohsiung City, 123, Taiwan
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05722067
Lead sponsor
Chang Gung Memorial Hospital
Responsible party
Sponsor
First posted
Feb 10, 2023
Start date
Jan 1, 2023
Primary completion
Mar 23, 2025
Completion
Jun 30, 2025
Last update
Mar 20, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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