In Vitro FertilizationPhase 2/3NCT02992665
Can Calcium Ionophore Application Enhance the ICSI Outcomes in Severe Male Factor Infertility?
A Phase 2/3 study testing Ca Ionophore A23187 in people with In Vitro Fertilization and Male Factor Infertility, run by Assiut University at 1 site in Egypt.
Trial summary
The purpose of this study is to determine the impact of the use of calcium ionophore on the ICSI outcomes in couples with severe male factor infertility. Investigators conduct a randomized controlled trial on the sibling oocyte to justify the use of calcium ionophore in these cases. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- In Vitro Fertilization, Male Factor Infertility
- What is being tested?
- Ca Ionophore A23187
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- Dec 2016to Dec 2017
- Phase
- Phase 2/3
- 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 18 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Severe male factor infertility, Average response to COH,
Who cannot join
- Poor responders,
Trial locations and contacts
1 site in 1 country.
Osama Abdalmageed contact
Egypt1 site, 1 recruiting
- Recruiting
Osama Abdalmageed
Asyut, Asyut Governorate, 71515
Osama Abdalmageed, 1007972027, drosamast@yahoo.com.au
Osama Abdalmageed, 1007972027 ext. Abdalmageed
About this study
The purpose of this study is to determine the impact of the use of calcium ionophore on the ICSI outcomes in couples with severe male factor infertility. Investigators conduct a randomized controlled trial on the sibling oocyte to justify the use of calcium ionophore in these cases.
Read the detailed description
Elevation of calcium levels inside the oocyte is one of the most initial steps which takes place during normal fertilization (1). The interaction between the sperm and oocytes surface protein receptors may be the triggering event for oocyte activation during the process of fertilization (2). It is suggested that the process of intracellular Calcium elevation is triggered by binding of the sperm to the oocyte oolemma and hence the fertilization starts (3). Severe male factor couples might have compromised fertilization and pregnancy outcomes (4).
A prospective multicenter non-randomized study indicated that calcium ionophore could improve the fertilization as well as the clinical pregnancy rates in these patients (5). On the other hand, a randomized controlled trial did not find any significance for the use of calcium ionophore in the couples with poor ovarian reserve with regards the fertilization and clinical pregnancy rates (6). The purpose of this study is to determine the impact of the use of calcium ionophore on the ICSI outcomes in couples with severe male factor infertility. Investigators conduct a randomized controlled trial on the sibling oocyte to justify the use of calcium ionophore in these cases.
- Conditions
- In Vitro Fertilization, Male Factor Infertility
- Being tested
- Ca Ionophore A23187, Placebo
- Keywords
- Calcium ionophore, Fertilization, Sperm, Oocyte, ICSI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ca Ionophore A23187Drug
Also called Ca ionophore
Sibling oocytes are to be randomized to artificially activated using Calcium ionophore in cases with severely compromized semen parameters
PlaceboOther
Placebo is used to control Ca ionophore group
| Study group | Role | What they receive |
|---|---|---|
| Ca ionophore | Experimental | Artificial activation of the oocytes using Calcium ionophore in the cases of severe male factor infertility. Receives: Drug: Ca Ionophore A23187 |
| Placebo | Experimental | Placebo was used to control the group of Calcium ionophore Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fertilization rate
Measured: 18 hours after injecting the sperms in the oocytes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2016 (estimated)
- Study startDec 2016
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for In Vitro FertilizationStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Osama Saber Thabet Abdalmageed, Assiut University
- Investigators
- Osama Abdalmageed, Principal investigator, Women health center, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02992665
- Sponsor's protocol ID
- CaII
- Status last verified
- Dec 2016
- First submitted
- 11 Dec 2016
- Last updated
- 14 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided: According to the patient agreement.
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Calcium Ionophore Application Enhance the ICSI Outcomes in Severe Male Factor Infertility?
- ClinicalTrials.gov ID
- NCT02992665
- Acronym / sponsor ID
- CaII
- Conditions
- In Vitro Fertilization, Male Factor Infertility
- Keywords
- Calcium ionophore, Fertilization, Sperm, Oocyte, ICSI
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 14 Dec 2016 (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 purpose of this study is to determine the impact of the use of calcium ionophore on the ICSI outcomes in couples with severe male factor infertility. Investigators conduct a randomized controlled trial on the sibling oocyte to justify the use of calcium ionophore in these cases.
Detailed description
Elevation of calcium levels inside the oocyte is one of the most initial steps which takes place during normal fertilization (1). The interaction between the sperm and oocytes surface protein receptors may be the triggering event for oocyte activation during the process of fertilization (2). It is suggested that the process of intracellular Calcium elevation is triggered by binding of the sperm to the oocyte oolemma and hence the fertilization starts (3). Severe male factor couples might have compromised fertilization and pregnancy outcomes (4).
A prospective multicenter non-randomized study indicated that calcium ionophore could improve the fertilization as well as the clinical pregnancy rates in these patients (5). On the other hand, a randomized controlled trial did not find any significance for the use of calcium ionophore in the couples with poor ovarian reserve with regards the fertilization and clinical pregnancy rates (6). The purpose of this study is to determine the impact of the use of calcium ionophore on the ICSI outcomes in couples with severe male factor infertility. Investigators conduct a randomized controlled trial on the sibling oocyte to justify the use of calcium ionophore in these cases.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ca ionophore | Experimental | Drug: Ca Ionophore A23187Artificial activation of the oocytes using Calcium ionophore in the cases of severe male factor infertility. |
| Placebo | Experimental | Other: PlaceboPlacebo was used to control the group of Calcium ionophore |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Severe male factor infertility, Average response to COH,
Key exclusion criteria (1 listed)
- Poor responders,
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 |
|---|---|---|
| Ca Ionophore A23187Also: Ca ionophoreSibling oocytes are to be randomized to artificially activated using Calcium ionophore in cases with severely compromized semen parameters | Drug | Ca ionophore |
| PlaceboPlacebo is used to control Ca ionophore group | Other | Placebo |
Primary outcome
Fertilization rate
Time frame: 18 hours after injecting the sperms in the oocytes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2016.
- Individual participant dataSharing planned: Undecided. According to the patient agreement.
Related trials for In Vitro Fertilization
RecruitingObservational study
International Pilot Study for Dual Non-invasive Assesment of Embryo Development
Infertility
RecruitingPhase 2
Ubiquinone vs. Ubiquinol Supplementation
IVF
Recruiting
Trigger Timing in Ovarian Stimulations
IVF Outcome
Active, not recruiting
Automation of the In Vitro Fertilization Laboratory
Infertility, ART
RecruitingPhase 4
Study of G-CSF for DOR in Patients Undergoing IVF
Diminished Ovarian Reserve, IVF
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.
Osama Abdalmageed contact
Osama Abdalmageed principal investigator
Women health center, Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Ca Ionophore A23187 in people with In Vitro Fertilization and Male Factor Infertility, run by Assiut University at 1 site in Egypt.
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 1 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: status not confirmed, as of the sponsor's last update on 14 Dec 2016. 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 Egypt. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Osama Abdalmageed (drosamast1981@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fertilization rate (time frame: 18 hours after injecting the sperms in the oocytes). 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 14 Dec 2016.