Fertilization ArrestNCT02683031
Effect of Ca2+ Ionophore on Embryonic Development and Clinical Outcome in Cases With Previous Fertilization Arrest
A study testing Ca2+ ionophore in people with Fertilization Arrest, run by TopLab Company for ART Laboratories Consultation and Training at 1 site in Egypt.
Trial summary
We aimed to investigate the efficiency of chemical oocyte activation using readymade Ca2+ ionophore on cases with previously cancelled cases due to fertilization arrest at pronuclear stage i.e: cleavage failure to find out if there is any improvement in embryonic developmental stages. Read more about this study
- Who is it for?
- Ages 20 to 39 years, women only
- Conditions the study is for
- Fertilization Arrest
- What is being tested?
- Ca2+ ionophore
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- May 2014to Dec 2017
- 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 39 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Patients with previous history of complete fertilization arrest.
- ovarian stimulation with the GnRH agonist and recombinant FSH in a long protocol.
Who cannot join
- Female age >40 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Randomized Controlled Trial Investigating Embryonic Development and Clinical Outcome After Using Ca2+ Ionophore in Cases With Previous Fertilization Arrest
We aimed to investigate the efficiency of chemical oocyte activation using readymade Ca2+ ionophore on cases with previously cancelled cases due to fertilization arrest at pronuclear stage i.e: cleavage failure to find out if there is any improvement in embryonic developmental stages.
Read the detailed description
Many studies reported that Ca2+ ionophore has a positive effect on embryo development in cases with complete or partial fertilization failure. However, only one preliminary report suggested a beneficial effect of Ca2+ ionophore activation in four cases with fertilization arrest.
- Conditions
- Fertilization Arrest
- Being tested
- Ca2+ ionophore
- Keywords
- fertilization arrest, Cleavage failure, Embryonic development, Calcium ionophore
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ca2+ ionophoreOther
Also called A23187 Ca2+ ionophore
Ca2+ ionophore is a chemical agent used to perform oocyte activation after ICSI. It showed effective treatment to get better fertilization, pregnancy, and healthy livebirth in cases with total or partial fertilization failure.
| Study group | Role | What they receive |
|---|---|---|
| Without Ca2+ ionophore | No intervention | Patients with previous incomplete ICSI cycle due to fertilization arrest were counseled to underwent a subsequent conventional ICSI cycle. |
| With Ca2+ ionophore | Experimental | Patients with previous incomplete ICSI cycle due to fertilization arrest were counseled to underwent a subsequent ICSI cycle combined with artificial oocyte activation using Ca2+ ionophore. Receives: Other: Ca2+ ionophore |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blastocyst formation rate
Defined as the total number of blastocyst / total number of cleaved Embryos
Measured: 5 to 7days post oocyte retrival
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2016 (estimated)
- Study startMay 2014
- 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.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Fertilization ArrestStudies 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
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TopLab Company for ART Laboratories Consultation and Training
- Sponsor type
- University, hospital or other
- Collaborators
- Benha University
- Responsible party
- Principal investigator, Yasmin Magdi, Dar AlMaraa Center
- Investigators
- Yasmin Magdi, M.Sc, Principal investigator, Dar Almaraa fertility and gynacology centerMona M. Awady, MD, Study chair, Department of Community Medicine, Faculty of Medicine, Benha University, Benha, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02683031
- Sponsor's protocol ID
- #0010010
- Status last verified
- Aug 2016
- First submitted
- 11 Feb 2016
- Last updated
- 18 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Ebner T, Koster M, Shebl O, Moser M, Van der Ven H, Tews G, Montag M. Application of a ready-to-use calcium ionophore increases rates of fertilization and pregnancy in severe male factor infertility. Fertil Steril. 2012 Dec;98(6):1432-7. doi: 10.1016/j.fertnstert.2012.07.1134. Epub 2012 Aug 24.
PubMed 22921909Ebner T, Montag M; Oocyte Activation Study Group; Montag M, Van der Ven K, Van der Ven H, Ebner T, Shebl O, Oppelt P, Hirchenhain J, Krussel J, Maxrath B, Gnoth C, Friol K, Tigges J, Wunsch E, Luckhaus J, Beerkotte A, Weiss D, Grunwald K, Struller D, Etien C. Live birth after artificial oocyte activation using a ready-to-use ionophore: a prospective multicentre study. Reprod Biomed Online. 2015 Apr;30(4):359-65. doi: 10.1016/j.rbmo.2014.11.012. Epub 2014 Dec 9.
PubMed 25596904Darwish E, Magdi Y. A preliminary report of successful cleavage after calcium ionophore activation at ICSI in cases with previous arrest at the pronuclear stage. Reprod Biomed Online. 2015 Dec;31(6):799-804. doi: 10.1016/j.rbmo.2015.08.012. Epub 2015 Aug 28.
PubMed 26507280
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Controlled Trial Investigating Embryonic Development and Clinical Outcome After Using Ca2+ Ionophore in Cases With Previous Fertilization Arrest
- ClinicalTrials.gov ID
- NCT02683031
- Acronym / sponsor ID
- #0010010
- Conditions
- Fertilization Arrest
- Keywords
- fertilization arrest, Cleavage failure, Embryonic development, Calcium ionophore
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- TopLab Company for ART Laboratories Consultation and TrainingUniversity, hospital or other
- Collaborators
- Benha University
- Study start
- May 2014
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 17 Feb 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.
We aimed to investigate the efficiency of chemical oocyte activation using readymade Ca2+ ionophore on cases with previously cancelled cases due to fertilization arrest at pronuclear stage i.e: cleavage failure to find out if there is any improvement in embryonic developmental stages.
Detailed description
Many studies reported that Ca2+ ionophore has a positive effect on embryo development in cases with complete or partial fertilization failure. However, only one preliminary report suggested a beneficial effect of Ca2+ ionophore activation in four cases with fertilization arrest.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Without Ca2+ ionophore | No intervention | –Patients with previous incomplete ICSI cycle due to fertilization arrest were counseled to underwent a subsequent conventional ICSI cycle. |
| With Ca2+ ionophore | Experimental | Other: Ca2+ ionophorePatients with previous incomplete ICSI cycle due to fertilization arrest were counseled to underwent a subsequent ICSI cycle combined with artificial oocyte activation using Ca2+ ionophore. |
Who may qualify
- Ages
- 20 to 39 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients with previous history of complete fertilization arrest.
- ovarian stimulation with the GnRH agonist and recombinant FSH in a long protocol.
Key exclusion criteria (1 listed)
- Female age >40 years
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 |
|---|---|---|
| Ca2+ ionophoreAlso: A23187 Ca2+ ionophoreCa2+ ionophore is a chemical agent used to perform oocyte activation after ICSI. It showed effective treatment to get better fertilization, pregnancy, and healthy livebirth in cases with total or partial fertilization failure. | Other | With Ca2+ ionophore |
Primary outcome
Blastocyst formation rate
Time frame: 5 to 7days post oocyte retrival
Defined as the total number of blastocyst / total number of cleaved Embryos
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2016.
- Background: PubMed 22921909Ebner T, Koster M, Shebl O, Moser M, Van der Ven H, Tews G, Montag M. Application of a ready-to-use calcium ionophore increases rates of fertilization and pregnancy in severe male factor infertility. Fertil Steril. 2012 Dec;98(6):1432-7. doi: 10.1016/j.fertnstert.2012.07.1134. Epub 2012 Aug 24.
- Background: PubMed 25596904Ebner T, Montag M; Oocyte Activation Study Group; Montag M, Van der Ven K, Van der Ven H, Ebner T, Shebl O, Oppelt P, Hirchenhain J, Krussel J, Maxrath B, Gnoth C, Friol K, Tigges J, Wunsch E, Luckhaus J, Beerkotte A, Weiss D, Grunwald K, Struller D, Etien C. Live birth after artificial oocyte activation using a ready-to-use ionophore: a prospective multicentre study. Reprod Biomed Online. 2015 Apr;30(4):359-65. doi: 10.1016/j.rbmo.2014.11.012. Epub 2014 Dec 9.
- Results publication: PubMed 26507280Darwish E, Magdi Y. A preliminary report of successful cleavage after calcium ionophore activation at ICSI in cases with previous arrest at the pronuclear stage. Reprod Biomed Online. 2015 Dec;31(6):799-804. doi: 10.1016/j.rbmo.2015.08.012. Epub 2015 Aug 28.
- Individual participant dataSharing planned: Undecided
Related trials for Fertilization Arrest
Recruiting
HELIOS Advanced: Human Oocyte Illumination to Enhance Development
IVF Outcomes
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.
Yasmin Magdi, M.Sc principal investigator
Dar Almaraa fertility and gynacology center
Mona M. Awady, MD study chair
Department of Community Medicine, Faculty of Medicine, Benha University, Benha, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ca2+ ionophore in people with Fertilization Arrest, run by TopLab Company for ART Laboratories Consultation and Training 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 2 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 18 Aug 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.
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 Yasmin Magdi, M.Sc (+201282313979, Yas.magdi@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blastocyst formation rate (time frame: 5 to 7days post oocyte retrival). 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 NCT02683031, which also lists 3 linked publications.
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 18 Aug 2016.