InfertilityCISCNCT02418416
Novel Approach With Double Agent Artificial Oocyte Activation for Repeated Fertilization Failure Due to Combined Sperm and Oocyte Factor
A study testing Oocyte double chemical activation in people with Infertility, run by Ibn Sina Hospital at 3 sites in 2 countries.
Trial summary
Novel approach for Oocyte fertilization failure for difficult cases not respond to traditional methods of assisted reproduction as intracytoplasmic sperm injection. Read more about this study
- Who is it for?
- Ages 18 to 44 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility
- What is being tested?
- Oocyte double chemical activation
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 6 May 2015to Jun 2016
- 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 18 to 44 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- poor sperm
- poor quality Oocytes
- previous failed fertilization
- previous poor embryogenesis
Who cannot join
- normal patient
- previous successful outcome
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Egypt2 sites
Banon fertility center
Asyut
IbnSina IVF unit, IbnSina Hospital, El Areef Square
Sohag, 12345
About this study
Official title: Calcium Ionophore Together With Strontium Chloride Would Likely Have a Positive But Non-traumatic Impact on Human Embryo Development
Novel approach for Oocyte fertilization failure for difficult cases not respond to traditional methods of assisted reproduction as intracytoplasmic sperm injection.
Read the detailed description
In some cases undergoes assisted reproduction technique specially Intracytoplasmic sperm injection, in subgroup of patient they fail to fertilize or poorly fertilized, some authors recommend chemical activation for those group of patient with Ca ionophore but still with Ca ionophore there are some cases with total fertilization failure or low fertilization specially in those patient with 2 separate factors like teratozoospermia with poor quality Oocytes so the investigators decided to test the effect of double activation methods by using tow agents proven with life birth rate Ca ionophore and strontium chloride.
We Do intracytoplasmic sperm injection and immediately activate oocyte with Ca Ionophore followed by strontium chloride activation and monitoring the embryogenesis until the blastocyst formation and pregnancy outcome in multicenter assessment.
- Conditions
- Infertility
- Being tested
- Oocyte double chemical activation
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oocyte double chemical activationOther
Oocyte double chemical activation
| Study group | Role | What they receive |
|---|---|---|
| Double activation | Experimental | The Oocytes in this arm will undergo double activation with Ca ionophore 5 micro mol for 20 min them Strontium chloride 10 micro mol for 60 min. Receives: Other: Oocyte double chemical activation |
| Control arm | No intervention | The Oocytes will undergo Intracytoplasmic sperm injection only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Pregnancy rate ( % )
To predict percentage of pregnant women from those will undergo Embryo transfer
Measured: 3 months
Secondary outcomes (1)
Blastocyst rate ( % )
Number of embryos will reach blastocyst stage at day 5 post Intracytoplasmic sperm injection
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2015 (estimated)
- Study start6 May 2015
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ibn Sina Hospital
- Sponsor type
- Other government
- Collaborators
- Al Baraka Fertility Hospital, Banon IVF Center Assiut, Egypt
- Responsible party
- Principal investigator, Muhammad Fawzy, Ibn Sina Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02418416
- Sponsor's protocol ID
- IbnSina Hospital IVF
- Acronym
- CISC
- Status last verified
- Sep 2018
- First submitted
- 6 Apr 2015
- Last updated
- 27 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Calcium Ionophore Together With Strontium Chloride Would Likely Have a Positive But Non-traumatic Impact on Human Embryo Development
- ClinicalTrials.gov ID
- NCT02418416
- Acronym / sponsor ID
- CISC / IbnSina Hospital IVF
- Conditions
- Infertility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Ibn Sina HospitalOther government
- Collaborators
- Al Baraka Fertility Hospital, Banon IVF Center Assiut, Egypt
- Study start
- 6 May 2015 (actual)
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 16 Apr 2015 (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.
Novel approach for Oocyte fertilization failure for difficult cases not respond to traditional methods of assisted reproduction as intracytoplasmic sperm injection.
Detailed description
In some cases undergoes assisted reproduction technique specially Intracytoplasmic sperm injection, in subgroup of patient they fail to fertilize or poorly fertilized, some authors recommend chemical activation for those group of patient with Ca ionophore but still with Ca ionophore there are some cases with total fertilization failure or low fertilization specially in those patient with 2 separate factors like teratozoospermia with poor quality Oocytes so the investigators decided to test the effect of double activation methods by using tow agents proven with life birth rate Ca ionophore and strontium chloride.
We Do intracytoplasmic sperm injection and immediately activate oocyte with Ca Ionophore followed by strontium chloride activation and monitoring the embryogenesis until the blastocyst formation and pregnancy outcome in multicenter assessment.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Double activation | Experimental | Other: Oocyte double chemical activationThe Oocytes in this arm will undergo double activation with Ca ionophore 5 micro mol for 20 min them Strontium chloride 10 micro mol for 60 min. |
| Control arm | No intervention | –The Oocytes will undergo Intracytoplasmic sperm injection only |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- poor sperm
- poor quality Oocytes
- previous failed fertilization
- previous poor embryogenesis
Key exclusion criteria (2 listed)
- normal patient
- previous successful outcome
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 |
|---|---|---|
| Oocyte double chemical activationOocyte double chemical activation | Other | Double activation |
Primary outcome
Clinical Pregnancy rate ( % )
Time frame: 3 months
To predict percentage of pregnant women from those will undergo Embryo transfer
1 secondary outcome
Blastocyst rate ( % )
Time frame: 3 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 27 Sep 2018.
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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.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oocyte double chemical activation in people with Infertility, run by Ibn Sina Hospital at 3 sites in 2 countries.
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 4 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: finished, as of the sponsor's last update on 27 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Egypt, Bahrain. 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?
Clinical Pregnancy rate ( % ) (time frame: 3 months). 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 27 Sep 2018.