Infertility, FemaleCalciferNCT06106412
Efficacy of Oocyte Activation With Two Types of Ca2+ Ionophore.
A study testing Ionomycin SIGMA and A23187 in people with Infertility, Female, run by Instituto Valenciano de Infertilidad, IVI VALENCIA at 1 site in Spain.
Trial summary
This study is a prospective ranzomized analysis including 372 human oocytes from 44 women. Half of the oocytes from the same patient will be randomly allocated to induce oocyte activation using two protocols: in protocol nº 1 we will use ionomycin (prepared solution), protocol nª2 A23187 (GM508 CultActive Gynemed)… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Infertility, Female
- What is being tested?
- Ionomycin SIGMA and A23187
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2024to Dec 2024
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Own oocyte patients who have had previous fertilization failure in previous cycles.
- Own oocyte patients with fertilization rate in previous cycles less than or equal to 30% of the microinjected oocytes.
Who cannot join
- Oocyte Recipient Patients
- Sperm bank sperm recipient patients
- Patients who after oocyte decumulation have less than 2 mature oocytes.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Ivirma Valencia
Valencia, 46015
Maria Jose DeLosSantos, PhD, +34963050900, mjdelossantos@ivirma.com
Maria Jose DeLosSantos, PhD
About this study
Official title: Efficacy of Oocyte Activation With Two Types of Ca2+ Ionophore: a Prospective Randomized Study.
This study is a prospective ranzomized analysis including 372 human oocytes from 44 women. Half of the oocytes from the same patient will be randomly allocated to induce oocyte activation using two protocols: in protocol nº 1 we will use ionomycin (prepared solution), protocol nª2 A23187 (GM508 CultActive Gynemed) will be applied. Non treated oocytes will serve as control. Oocyte fertilization rates, embryo development and embryo quality will be analyzed. Obstetrics variables of offspring will be also followed and compared.
Read the detailed description
Background: Oocyte non-activation (OAD) is the main cause of fertilization failure in intracytoplasmic sperm injection (ICSI) cycles. Oocyte activation involves a series of consecutive events that take place in the oocyte during fertilization, triggered by the action of sperm-specific phospholipase C zeta (PLCz) that causes an increase in the amount of free Ca2+. This increase, as well as its transient elevations in space and time, is species-specific. Defects in this pattern of Ca2+ release and oscillation are attributed to most cases of OAD. Several strategies have been described and applied to achieve artificial oocyte activation (AOA), which use mechanical, electrical, or chemical stimuli, among which the use of calcium ionophores such as ionomycin and A23187 (calcimycin) predominates. Documented fertilization and pregnancy rates appear to be improved in patients with previous low fertilization rates or total fertilization failures after using ICSI-AOA compared to conventional ICSI. However, the lack of well-designed studies, the heterogeneity of the population undergoing AOA, and the scarcity of results comparing different AOA protocols make it difficult to assess the clinical efficacy and safety of the technique.
Study question: In patients with prior fertilization failure or low fertilization rates (30% or less), does AOA improve reproductive outcomes compared to conventional ICSI in patients with prior fertilization failure? and if it does, which protocol is more efficient?
- Conditions
- Infertility, Female
- Being tested
- Ionomycin SIGMA, A23187
- Keywords
- Artificial oocyte activation, Fertilization Failure, Calcium ionophore, Ionomycin, Calcimycin, Fertilization rate
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ionomycin SIGMADrug
Oocytes will be activated with Ionomycin SIGMA
A23187Drug
Oocytes will be activated with A23187
| Study group | Role | What they receive |
|---|---|---|
| GROUP 1 IONOMYCIN SIGMA | Experimental | The oocytes obtained from the patients allocated to this group will be subdivided again in two groups Group 1a: Oocytes treated with SIGMA ionomycin (treatment). Group 1b: Oocytes that will not be treated with any activator (Control). Receives: Drug: Ionomycin SIGMA |
| GROUP 2 A23187 | Active comparator | The oocytes obtained from the patients allocated to this group will be subdivided again in two groups Group 2a: Oocytes treated with A23187 (treatment). Group 2b: Oocytes that will not be treated with any activator (Control). Receives: Drug: A23187 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in the percetage of usable blastocyst per injeected oocyte
To evaluate which AOA protocol with the use of two calcium (Ca2+) ionophores, ionomycin and A23187 (calcimycin), is better (improvement from 15% to 25%)
Measured: 1 YEAR
Secondary outcomes (2)
Sequencing unfertilized oocytes and arrested embryos using RNAseq
To quantify sequenced oocytes and arrested embryos after using RNAseq
Measured: 1 year
Quantification of PLCZ in sperm cells by flow
To quantify PLCZ in sperm
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 posted30 Oct 2023
- Study start1 Jan 2024
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility, FemaleStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective ranzomized analysis
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Valenciano de Infertilidad, IVI VALENCIA
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06106412
- Sponsor's protocol ID
- 2303-VLC-043-MD
- Acronym
- Calcifer
- Status last verified
- Mar 2024
- First submitted
- 23 Oct 2023
- Last updated
- 13 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Oocyte Activation With Two Types of Ca2+ Ionophore: a Prospective Randomized Study.
- ClinicalTrials.gov ID
- NCT06106412
- Acronym / sponsor ID
- Calcifer / 2303-VLC-043-MD
- Conditions
- Infertility, Female
- Keywords
- Artificial oocyte activation, Fertilization Failure, Calcium ionophore, Ionomycin, Calcimycin, Fertilization rate
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Instituto Valenciano de Infertilidad, IVI VALENCIAUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 30 Oct 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.
This study is a prospective ranzomized analysis including 372 human oocytes from 44 women. Half of the oocytes from the same patient will be randomly allocated to induce oocyte activation using two protocols: in protocol nº 1 we will use ionomycin (prepared solution), protocol nª2 A23187 (GM508 CultActive Gynemed) will be applied. Non treated oocytes will serve as control. Oocyte fertilization rates, embryo development and embryo quality will be analyzed. Obstetrics variables of offspring will be also followed and compared.
Detailed description
Background: Oocyte non-activation (OAD) is the main cause of fertilization failure in intracytoplasmic sperm injection (ICSI) cycles. Oocyte activation involves a series of consecutive events that take place in the oocyte during fertilization, triggered by the action of sperm-specific phospholipase C zeta (PLCz) that causes an increase in the amount of free Ca2+. This increase, as well as its transient elevations in space and time, is species-specific. Defects in this pattern of Ca2+ release and oscillation are attributed to most cases of OAD. Several strategies have been described and applied to achieve artificial oocyte activation (AOA), which use mechanical, electrical, or chemical stimuli, among which the use of calcium ionophores such as ionomycin and A23187 (calcimycin) predominates. Documented fertilization and pregnancy rates appear to be improved in patients with previous low fertilization rates or total fertilization failures after using ICSI-AOA compared to conventional ICSI. However, the lack of well-designed studies, the heterogeneity of the population undergoing AOA, and the scarcity of results comparing different AOA protocols make it difficult to assess the clinical efficacy and safety of the technique.
Study question: In patients with prior fertilization failure or low fertilization rates (30% or less), does AOA improve reproductive outcomes compared to conventional ICSI in patients with prior fertilization failure? and if it does, which protocol is more efficient?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective ranzomized analysis
| Arm | Type | Receives |
|---|---|---|
| GROUP 1 IONOMYCIN SIGMA | Experimental | Drug: Ionomycin SIGMAThe oocytes obtained from the patients allocated to this group will be subdivided again in two groups Group 1a: Oocytes treated with SIGMA ionomycin (treatment). Group 1b: Oocytes that will not be treated with any activator (Control). |
| GROUP 2 A23187 | Active comparator | Drug: A23187The oocytes obtained from the patients allocated to this group will be subdivided again in two groups Group 2a: Oocytes treated with A23187 (treatment). Group 2b: Oocytes that will not be treated with any activator (Control). |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Own oocyte patients who have had previous fertilization failure in previous cycles.
- Own oocyte patients with fertilization rate in previous cycles less than or equal to 30% of the microinjected oocytes.
Key exclusion criteria (3 listed)
- Oocyte Recipient Patients
- Sperm bank sperm recipient patients
- Patients who after oocyte decumulation have less than 2 mature oocytes.
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 |
|---|---|---|
| Ionomycin SIGMAOocytes will be activated with Ionomycin SIGMA | Drug | GROUP 1 IONOMYCIN SIGMA |
| A23187Oocytes will be activated with A23187 | Drug | GROUP 2 A23187 |
Primary outcome
Improvement in the percetage of usable blastocyst per injeected oocyte
Time frame: 1 YEAR
To evaluate which AOA protocol with the use of two calcium (Ca2+) ionophores, ionomycin and A23187 (calcimycin), is better (improvement from 15% to 25%)
2 secondary outcomes
Sequencing unfertilized oocytes and arrested embryos using RNAseq
Time frame: 1 year
Quantification of PLCZ in sperm cells by flow
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
Related trials for Infertility, Female
Recruiting
Endometriosis Transcriptomic Cell Atlas
Endometriosis, Infertility
RecruitingPhase 1
Efficacy of Injectable Vitamin D Supplementation in Females With Polycystic Ovary Syndrome
Anovulatory Infertility
RecruitingPhase 2
A Study to Investigate Mibavademab in Adult Women With Functional Hypothalamic Amenorrhea
Functional Hypothalamic Amenorrhea, FHA
Not yet recruitingPhase 2
PRECISION-E2: Teverelix in Women With Endometriosis - Pharmacodynamics, Safety and Precision Medicine Correlates
Endometriosis Pelvic, Endometriosis Ovaries
Recruiting
Clinical Impact of Uterine Repair During Cesarean Section With Barbed Suture on the Incidence of Isthmocele
Isthmocele, Cesarean Scar Defect
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ionomycin SIGMA and A23187 in people with Infertility, Female, run by Instituto Valenciano de Infertilidad, IVI VALENCIA at 1 site in Spain.
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 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: status not confirmed, as of the sponsor's last update on 13 Mar 2024. 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 Spain. 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 LAURA CARACENA, Msr (963.050900, LAURA.CARACENA@IVIRMA.COM), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in the percetage of usable blastocyst per injeected oocyte (time frame: 1 YEAR). 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 13 Mar 2024.