InfertilityNCT01595815
Successful Pregnancy and Delivery After AOA
A study testing Calcium ionophore and Strontium chloride (SrCl2) in people with Infertility, run by Maria Fertility Hospital at 1 site in South Korea.
Trial summary
Artificial oocyte activation with strontium chloride or calcium ionophore improves fertilization, embryo quality, pregnancy and delivery rate in women who showed complete fertilization failure or low fertilization rates Read more about this study
- Who is it for?
- Ages 20 to 45 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Calcium ionophore and Strontium chloride (SrCl2)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2007to Apr 2014
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Fertilization rate was less than 30% after conventional ICSI.
- Fertilization rate was less than 50% after ICSI with calcium ionophore.
- Repeated complete fertilization failure or low fertilization rates following ICSI in previous cycles
Who cannot join
- Fertilization rate was more than 30% after conventional ICSI
- Fertilization rate was more than 50% after ICSI with calcium ionophore.
- Successful pregnancy and delivery after ICSI in previous cycles
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Successful Pregnancy and Delivery After AOA in Couples With Repeated Complete Fertilization Failure or Low Fertilization Rates
Artificial oocyte activation with strontium chloride or calcium ionophore improves fertilization, embryo quality, pregnancy and delivery rate in women who showed complete fertilization failure or low fertilization rates
- Conditions
- Infertility
- Being tested
- Calcium ionophore, Strontium chloride (SrCl2)
- Keywords
- Fertilization failure, calcium ionophore, SrCl2
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcium ionophoreOther
Oocytes were activated with calcium ionophore after ICSI
Strontium chloride (SrCl2)Other
Oocytes were activated with strontium chloride after ICSI
| Study group | Role | What they receive |
|---|---|---|
| Conventional ICSI | Active comparator | The couple showed complete fertilization failure after ICSI. Receives: Other: Calcium ionophore; Other: Strontium chloride (SrCl2) |
| Convention ICSI | Active comparator | The couple showed a low fertilization rates after ICSI. Receives: Other: Calcium ionophore; Other: Strontium chloride (SrCl2) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fertilization rate
Measured: 18 hours
Secondary outcomes (3)
Embryo quality
Measured: 3 Days
Pregnancy and Implantation rates
Measured: 2 months
Assessment of Infant health care
This assessment is according to the standard set by the National Health Insurance Service (NHIS) in Korea.
Measured: birth and at 3, 6, 12, 24, 36, 60, and 72 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2012 (estimated)
- Study startMay 2007
- Primary completionSep 2011
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfertilityStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maria Fertility Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jun-Woo Kim, Principal Investigator, Maria Fertility Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01595815
- Sponsor's protocol ID
- GJHS120509DK
- Status last verified
- Jan 2014
- First submitted
- 9 May 2012
- Last updated
- 9 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kim JW, Yang SH, Yoon SH, Kim SD, Jung JH, Lim JH. Successful pregnancy and delivery after ICSI with artificial oocyte activation by calcium ionophore in in-vitro matured oocytes: a case report. Reprod Biomed Online. 2015 Apr;30(4):373-7. doi: 10.1016/j.rbmo.2014.11.014. Epub 2014 Dec 11.
PubMed 25592974
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Successful Pregnancy and Delivery After AOA in Couples With Repeated Complete Fertilization Failure or Low Fertilization Rates
- ClinicalTrials.gov ID
- NCT01595815
- Acronym / sponsor ID
- GJHS120509DK
- Conditions
- Infertility
- Keywords
- Fertilization failure, calcium ionophore, SrCl2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Maria Fertility HospitalUniversity, hospital or other
- Study start
- May 2007
- Primary completion
- Sep 2011 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 10 May 2012 (estimated)
- 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.
Artificial oocyte activation with strontium chloride or calcium ionophore improves fertilization, embryo quality, pregnancy and delivery rate in women who showed complete fertilization failure or low fertilization rates
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional ICSI | Active comparator | Other: Calcium ionophore, Other: Strontium chloride (SrCl2)The couple showed complete fertilization failure after ICSI. |
| Convention ICSI | Active comparator | Other: Calcium ionophore, Other: Strontium chloride (SrCl2)The couple showed a low fertilization rates after ICSI. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Fertilization rate was less than 30% after conventional ICSI.
- Fertilization rate was less than 50% after ICSI with calcium ionophore.
- Repeated complete fertilization failure or low fertilization rates following ICSI in previous cycles
Key exclusion criteria (3 listed)
- Fertilization rate was more than 30% after conventional ICSI
- Fertilization rate was more than 50% after ICSI with calcium ionophore.
- Successful pregnancy and delivery after ICSI in previous cycles
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 ionophoreOocytes were activated with calcium ionophore after ICSI | Other | Convention ICSI, Conventional ICSI |
| Strontium chloride (SrCl2)Oocytes were activated with strontium chloride after ICSI | Other | Convention ICSI, Conventional ICSI |
Primary outcome
Fertilization rate
Time frame: 18 hours
3 secondary outcomes
Embryo quality
Time frame: 3 Days
Pregnancy and Implantation rates
Time frame: 2 months
Assessment of Infant health care
Time frame: birth and at 3, 6, 12, 24, 36, 60, and 72 months
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 9 May 2025.
- Derived from this study: PubMed 25592974Kim JW, Yang SH, Yoon SH, Kim SD, Jung JH, Lim JH. Successful pregnancy and delivery after ICSI with artificial oocyte activation by calcium ionophore in in-vitro matured oocytes: a case report. Reprod Biomed Online. 2015 Apr;30(4):373-7. doi: 10.1016/j.rbmo.2014.11.014. Epub 2014 Dec 11.
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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 and Strontium chloride (SrCl2) in people with Infertility, run by Maria Fertility Hospital at 1 site in South Korea.
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 3 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 9 May 2025. 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 South Korea. 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: 18 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01595815, which also lists 1 linked publication.
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 9 May 2025.