IVFGM508 in IVFNCT05722067
Improvement of Fertilization Rate and Embryo Quality by Treating Calcium Ionophore in IVF Patients: a Sibling Oocyte Control Study
A study testing calcium ionophore in people with IVF and Infertility, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 to 50 years, women only
- Conditions the study is for
- IVF, Infertility, Artificial Oocyte Activation
- What is being tested?
- calcium ionophore
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2023to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- Without or just one oocyte picked up
Trial locations and contacts
1 site in 1 country.
About this study
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
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).
- Conditions
- IVF, Infertility, Artificial Oocyte Activation
- Being tested
- calcium ionophore
- Keywords
- artificial oocyte activation, calcium ionophore, ivf, poor responder
- Medical subject headings
- Infertility, Long Qt Syndrome 3
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
calcium ionophoreOther
Also called GM508 CultActive
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 group | Role | What they receive |
|---|---|---|
| oocytes treated with calcium ionophore | Experimental | 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. Receives: Other: calcium ionophore |
| oocytes undergo routine IVF/ICSI protocol | No intervention | Untreated control oocytes will immediately place into the time-lapse imaging system, and the culture protocol was routine. |
What is being measured
The primary outcome is the main question the study is designed to answer.
fertilization rate
The normal fertilization rate will defined as the number of zygotes with 2PN and 2PB per the total number of mature oocytes
Measured: Day 1
Secondary outcomes (3)
blastocyst formation rate
NO. of blastocysts per 2PN zygotes
Measured: Day 5
top-quality blastocyst formation rate
No. of 3AA, 4AA, 5AA or 6AA blastocysts / 2PN zygotes
Measured: Day 5
pregnancy outcome
pregnancy rates, abortion rate, live birth rates,congenital anomaly rate
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2023
- Study start1 Jan 2023
- Primary completion23 Mar 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IVFStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05722067
- Sponsor's protocol ID
- 202200969A3
- Acronym
- GM508 in IVF
- Status last verified
- Mar 2026
- First submitted
- 20 Nov 2022
- Last updated
- 20 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05722067
- Acronym / sponsor ID
- GM508 in IVF / 202200969A3
- Conditions
- IVF, Infertility, Artificial Oocyte Activation
- Keywords
- artificial oocyte activation, calcium ionophore, ivf, poor responder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 23 Mar 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 10 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| oocytes treated with calcium ionophore | Experimental | Other: calcium ionophoreOocytes 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. |
| oocytes undergo routine IVF/ICSI protocol | No intervention | –Untreated control oocytes will immediately place into the time-lapse imaging system, and the culture protocol was routine. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Without or just one oocyte picked up
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| calcium ionophoreAlso: GM508 CultActiveThe 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. | Other | oocytes treated with calcium ionophore |
Primary outcome
fertilization rate
Time frame: Day 1
The normal fertilization rate will defined as the number of zygotes with 2PN and 2PB per the total number of mature oocytes
3 secondary outcomes
blastocyst formation rate
Time frame: Day 5
top-quality blastocyst formation rate
Time frame: Day 5
pregnancy outcome
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing calcium ionophore in people with IVF and Infertility, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fertilization rate (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2026.