Oocyte FertilizationNCT02424214
Artificial Oocyte Activation Comparing Tow Different Agents
A study testing Artificial Oocyte activation, Ca Ionophore and Strontium Chloride in people with Oocyte Fertilization, run by Ibn Sina Hospital at 3 sites in 2 countries.
Trial summary
Comparing the efficacy of tow factors for artificial Oocyte Activation for poor quality Oocytes and Teratozoospermia patients. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Oocyte Fertilization
- What is being tested?
- Artificial Oocyte activation, Ca Ionophore and Strontium Chloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Apr 2015to Jan 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- previous fertilization failure
- poor quality Oocytes
- poor sperms
Who cannot join
- normal patients
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
About this study
Comparing the efficacy of tow factors for artificial Oocyte Activation for poor quality Oocytes and Teratozoospermia patients.
Read the detailed description
The IVF outcome had been varied widely with a good portion of total fertilization failure even after the most advanced procedure for this group of patient Intracytoplasmic Sperm Injection, many factors that had been tested for assisting the failed group of patient to be fertilized artificially like Ca Ionophore, Strontium Chloride and others but we decide to compare the clinically proven factors for the efficacy and safety in a well randomized clinical trial and monitor the embryogenesis and pregnancy within the 2 groups.
- Conditions
- Oocyte Fertilization
- Being tested
- Artificial Oocyte activation, Ca Ionophore, Strontium Chloride
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artificial Oocyte activationOther
Ca IonophoreDrug
Strontium ChlorideDrug
| Study group | Role | What they receive |
|---|---|---|
| Ca Ionophore group | Experimental | Artificial Oocyte activation with Ca Ionophore for 20 min after Intracytoplasmic Sperm Injection Receives: Other: Artificial Oocyte activation; Drug: Ca Ionophore |
| Strontium Chloride group | Experimental | Artificial Oocyte activation with Strontium Chloride for 60 min after Intracytoplasmic Sperm Injection Receives: Other: Artificial Oocyte activation; Drug: Strontium Chloride |
| Only Intracytoplasmic Sperm Injection | No intervention | after Intracytoplasmic Sperm Injection Oocytes will cultured and incubated |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pregnancy rate ( % )
Measured: 9 months
Secondary outcomes (1)
Blastocyst rate ( % )
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2015 (estimated)
- Study startApr 2015
- Primary completionJan 2016
- Study completionJan 2016
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 Oocyte FertilizationStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 450 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
- NCT02424214
- Sponsor's protocol ID
- IbnSina Oocyte activation
- Status last verified
- Feb 2018
- First submitted
- 18 Apr 2015
- Last updated
- 19 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Fawzy M, Emad M, Mahran A, Sabry M, Fetih AN, Abdelghafar H, Rasheed S. Artificial oocyte activation with SrCl2 or calcimycin after ICSI improves clinical and embryological outcomes compared with ICSI alone: results of a randomized clinical trial. Hum Reprod. 2018 Sep 1;33(9):1636-1644. doi: 10.1093/humrep/dey258.
PubMed 30099496
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Artificial Oocyte Activation Comparing Tow Different Agents
- ClinicalTrials.gov ID
- NCT02424214
- Acronym / sponsor ID
- IbnSina Oocyte activation
- Conditions
- Oocyte Fertilization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 450 participants (actual)
- Lead sponsor
- Ibn Sina HospitalOther government
- Collaborators
- Al Baraka Fertility Hospital, Banon IVF Center Assiut, Egypt
- Study start
- Apr 2015 (actual)
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 22 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.
Comparing the efficacy of tow factors for artificial Oocyte Activation for poor quality Oocytes and Teratozoospermia patients.
Detailed description
The IVF outcome had been varied widely with a good portion of total fertilization failure even after the most advanced procedure for this group of patient Intracytoplasmic Sperm Injection, many factors that had been tested for assisting the failed group of patient to be fertilized artificially like Ca Ionophore, Strontium Chloride and others but we decide to compare the clinically proven factors for the efficacy and safety in a well randomized clinical trial and monitor the embryogenesis and pregnancy within the 2 groups.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ca Ionophore group | Experimental | Other: Artificial Oocyte activation, Drug: Ca IonophoreArtificial Oocyte activation with Ca Ionophore for 20 min after Intracytoplasmic Sperm Injection |
| Strontium Chloride group | Experimental | Other: Artificial Oocyte activation, Drug: Strontium ChlorideArtificial Oocyte activation with Strontium Chloride for 60 min after Intracytoplasmic Sperm Injection |
| Only Intracytoplasmic Sperm Injection | No intervention | –after Intracytoplasmic Sperm Injection Oocytes will cultured and incubated |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- previous fertilization failure
- poor quality Oocytes
- poor sperms
Key exclusion criteria (1 listed)
- normal patients
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 |
|---|---|---|
| Artificial Oocyte activation | Other | Ca Ionophore group, Strontium Chloride group |
| Ca Ionophore | Drug | Ca Ionophore group |
| Strontium Chloride | Drug | Strontium Chloride group |
Primary outcome
Pregnancy rate ( % )
Time frame: 9 months
1 secondary outcome
Blastocyst rate ( % )
Time frame: 9 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 19 Feb 2018.
- Derived from this study: PubMed 30099496Fawzy M, Emad M, Mahran A, Sabry M, Fetih AN, Abdelghafar H, Rasheed S. Artificial oocyte activation with SrCl2 or calcimycin after ICSI improves clinical and embryological outcomes compared with ICSI alone: results of a randomized clinical trial. Hum Reprod. 2018 Sep 1;33(9):1636-1644. doi: 10.1093/humrep/dey258.
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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 Artificial Oocyte activation, Ca Ionophore and Strontium Chloride in people with Oocyte Fertilization, 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 3 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: finished, as of the sponsor's last update on 19 Feb 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?
Pregnancy rate ( % ) (time frame: 9 months). 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 NCT02424214, 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 19 Feb 2018.