Fertilization FailureNCT02045914
Calcium Ionophore Solution Can Increase Fertilization Rate in Patients During Intracytoplasmic Sperm Injection(ICSI) Who Have Poor Ovarian Reserve?
A study testing calcium ionophore solution in people with Fertilization Failure, run by Baskent University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to evaluate calcium ionophore solution on fertilization rate of patients during intracytoplasmic sperm injection who have poor ovarian reserve Read more about this study
- Who is it for?
- Ages 23 to 39 years, women only
- Conditions the study is for
- Fertilization Failure
- What is being tested?
- calcium ionophore solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2014to Aug 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 23 to 39 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- infertile couples who have no male factor infertility
- infertile females who are poor ovarian reserve
Who cannot join
- infertile couples who have male factor infertility
- infertile female who have endometriosis
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
baskent university obstetric and gynecology, reproductive endocrinology and IVF unit
Adana, Kisla, 01230
903224597249
pinar caglar aytac
About this study
Official title: Effect of Calcium Ionophore Solution on Fertilization Rate During ICSI Cycles of Poor Ovarian Reserve Patients
The aim of this study is to evaluate calcium ionophore solution on fertilization rate of patients during intracytoplasmic sperm injection who have poor ovarian reserve
Read the detailed description
During ICSI cycle , female patients who have poor ovarian reserve have low oocyte numbers. So by calcium ionophore solution which we know that it can increase fertilization rate in males who have azospermia or globozoospermia. we planned to check if this solution can increase fertilization rate also in poor ovarian reserve patients?
- Conditions
- Fertilization Failure
- Being tested
- calcium ionophore solution
- Keywords
- calcium ionophore, fertilization rate, poor ovarian reserve
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
calcium ionophore solutionOther
Also called GM 508 Cult-Active (Gynemed), ionomycin
After microinjection of sperm into the oocyte, oocytes are incubated for 15 minutes in a 30 microlitre droplet of calcium ionomycin solution
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | the patients who have no intervention with calcium ionophore during ICSI cycle |
| calcium ionophore | Experimental | the patients whose oocytes are incubated with calcium ionophore solution during ICSI cycle Receives: Other: calcium ionophore solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
calcium ionophore solution effect on fertilization rate
Before Intracytoplasmic sperm injection adding calcium ionophore solution to the medium can increase fertilization rate of oocytes or not?
Measured: 18 hours
Secondary outcomes (1)
Calcium ionophore solution increase on going pregnancy rate
İf the calcium ionophore can increase fertilization rate , pregnancy rate up to 20 weeks, can increase or not?
Measured: up to 21 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionApr 2014 (estimated)
- Study completionAug 2014 (estimated)
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 Fertilization FailureStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 162 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baskent University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pinar Caglar Aytac, Baskent University
- Investigators
- esra bulgan kilicdag, prof md, Study director, Baskent UniversityHuriye Ayse Parlakgumus, md, Study chair, Baskent UniversityPinar Caglar Aytac, md, Principal investigator, Baskent UniversityCok Tayfun, md, Study chair, Baskent UniversityBulent Haydardedeoglu, assoc Prof, Study chair, Baskent UniversityErhan Simsek, md, Study chair, Baskent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02045914
- Sponsor's protocol ID
- KA1-191
- Status last verified
- Jan 2014
- First submitted
- 23 Jan 2014
- Last updated
- 27 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Caglar Aytac P, Kilicdag EB, Haydardedeoglu B, Simsek E, Cok T, Parlakgumus HA. Can calcium ionophore "use" in patients with diminished ovarian reserve increase fertilization and pregnancy rates? A randomized, controlled study. Fertil Steril. 2015 Nov;104(5):1168-74. doi: 10.1016/j.fertnstert.2015.07.1163. Epub 2015 Sep 3.
PubMed 26342247
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Calcium Ionophore Solution on Fertilization Rate During ICSI Cycles of Poor Ovarian Reserve Patients
- ClinicalTrials.gov ID
- NCT02045914
- Acronym / sponsor ID
- KA1-191
- Conditions
- Fertilization Failure
- Keywords
- calcium ionophore, fertilization rate, poor ovarian reserve
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 162 participants (estimated)
- Lead sponsor
- Baskent UniversityUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Apr 2014 (estimated)
- Study completion
- Aug 2014 (estimated)
- First posted
- 27 Jan 2014 (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.
The aim of this study is to evaluate calcium ionophore solution on fertilization rate of patients during intracytoplasmic sperm injection who have poor ovarian reserve
Detailed description
During ICSI cycle , female patients who have poor ovarian reserve have low oocyte numbers. So by calcium ionophore solution which we know that it can increase fertilization rate in males who have azospermia or globozoospermia. we planned to check if this solution can increase fertilization rate also in poor ovarian reserve patients?
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –the patients who have no intervention with calcium ionophore during ICSI cycle |
| calcium ionophore | Experimental | Other: calcium ionophore solutionthe patients whose oocytes are incubated with calcium ionophore solution during ICSI cycle |
Who may qualify
- Ages
- 23 to 39 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- infertile couples who have no male factor infertility
- infertile females who are poor ovarian reserve
Key exclusion criteria (2 listed)
- infertile couples who have male factor infertility
- infertile female who have endometriosis
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 ionophore solutionAlso: GM 508 Cult-Active (Gynemed), ionomycinAfter microinjection of sperm into the oocyte, oocytes are incubated for 15 minutes in a 30 microlitre droplet of calcium ionomycin solution | Other | calcium ionophore |
Primary outcome
calcium ionophore solution effect on fertilization rate
Time frame: 18 hours
Before Intracytoplasmic sperm injection adding calcium ionophore solution to the medium can increase fertilization rate of oocytes or not?
1 secondary outcome
Calcium ionophore solution increase on going pregnancy rate
Time frame: up to 21 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2014.
- Derived from this study: PubMed 26342247Caglar Aytac P, Kilicdag EB, Haydardedeoglu B, Simsek E, Cok T, Parlakgumus HA. Can calcium ionophore "use" in patients with diminished ovarian reserve increase fertilization and pregnancy rates? A randomized, controlled study. Fertil Steril. 2015 Nov;104(5):1168-74. doi: 10.1016/j.fertnstert.2015.07.1163. Epub 2015 Sep 3.
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.
esra bulgan kilicdag, prof md study director
Baskent University
Huriye Ayse Parlakgumus, md study chair
Baskent University
Pinar Caglar Aytac, md principal investigator
Baskent University
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 solution in people with Fertilization Failure, run by Baskent University at 1 site in Turkey (Türkiye).
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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 27 Jan 2014. 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 Turkey (Türkiye). 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pinar Caglar Aytac, MD (905052796784, pinarcag1976@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
calcium ionophore solution effect on 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 NCT02045914, 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 27 Jan 2014; AzTrials last refreshed its copy on 6 Nov 2026.