InfertilityNCT03678584
Supplementing Intracytoplasmic Sperm Injection Handling Medium With Chaetoglobosin A ( ICSI-CA)
A study testing Medium Supplemented with Chaetoglobosin A in people with Infertility, run by Ibn Sina Hospital at 3 sites in Egypt.
Trial summary
Vienna Consensus has identified 10% damage rate after ICSI as a competency value. Despite the highest quality embryologists doing ICSI, degeneration sometimes occurs due to oocyte factors such as the fragile membrane, etc. Read more about this study
- Who is it for?
- Ages 18 to 42 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Medium Supplemented with Chaetoglobosin A
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 3 sitesEgypt
- Study dates
- 25 Sep 2018to 3 May 2019
- 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 42 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- All ICSI participants agreed
Who cannot join
- -
Trial locations and contacts
3 sites in 1 country.
Egypt3 sites
Banon Assiut
Asyut
Qena Fertility Center
Qina, Qena Governorate, 123456
IbnSina IVF Center, IbnSina Hospital
Sohag, 12345
About this study
Official title: Chaetoglobosin A Supplementation to ICSI Handling Medium
Vienna Consensus has identified 10% damage rate after ICSI as a competency value. Despite the highest quality embryologists doing ICSI, degeneration sometimes occurs due to oocyte factors such as the fragile membrane, etc. Chaetoglobosin A serves to facilitate spindle or pronuclear transfer procedures helping to reduce the damage rate with no harm reported. Using Chaetoglobosin A during ICSI could serve to rescue some oocytes from the degeneration allowing for more chances of viable zygotes.
- Conditions
- Infertility
- Being tested
- Medium Supplemented with Chaetoglobosin A
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medium Supplemented with Chaetoglobosin AOther
A medium with in-house supplementation of Chaetoglobosin A to decrease oocyte degeneration after ICSI and improve the survival rate
| Study group | Role | What they receive |
|---|---|---|
| Handling Medium Supplemented with Chaetoglobosin A | Experimental | Not described Receives: Other: Medium Supplemented with Chaetoglobosin A |
| handling Medium as it is. | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oocyte Survival after ICSI
Survived oocytes per MII injected
Measured: two days
Secondary outcomes (7)
Fertilization rate
Measured: 6 days of culture
Rate of top-quality embryo
Rate of top-quality embryo per fertilized oocytes
Measured: 6 days of culture
blastocyst formation and quality
Number of formed blastocyst and high-quality blastocyst per fertilized oocytes
Measured: 6 days of culture
blastocyst utilization rate
Number of transferred and vitrified embryos per fertilized oocytes
Measured: 6 days of culture
clinical pregnancy rate
Number of pregnant women per recruited cycles
Measured: 7 weeks
Implantation rate
sacs with a heartbeat per embryo transferred
Measured: 7 weeks
Ongoing pregnancy rate
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2018
- Study start25 Sep 2018
- Primary completion2 May 2019
- Study completion3 May 2019
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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ibn Sina Hospital
- Sponsor type
- Other government
- Collaborators
- Banoon IVF Center, Qena Fertility Center
- Responsible party
- Principal investigator, Muhammad Fawzy, Ibn Sina Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03678584
- Sponsor's protocol ID
- IbnSinaIVF-ICSI-CA
- Status last verified
- May 2019
- First submitted
- 17 Sep 2018
- Last updated
- 7 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chaetoglobosin A Supplementation to ICSI Handling Medium
- ClinicalTrials.gov ID
- NCT03678584
- Acronym / sponsor ID
- IbnSinaIVF-ICSI-CA
- Conditions
- Infertility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Ibn Sina HospitalOther government
- Collaborators
- Banoon IVF Center, Qena Fertility Center
- Study start
- 25 Sep 2018 (actual)
- Primary completion
- 2 May 2019 (actual)
- Study completion
- 3 May 2019 (actual)
- First posted
- 19 Sep 2018 (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.
Vienna Consensus has identified 10% damage rate after ICSI as a competency value. Despite the highest quality embryologists doing ICSI, degeneration sometimes occurs due to oocyte factors such as the fragile membrane, etc. Chaetoglobosin A serves to facilitate spindle or pronuclear transfer procedures helping to reduce the damage rate with no harm reported. Using Chaetoglobosin A during ICSI could serve to rescue some oocytes from the degeneration allowing for more chances of viable zygotes.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Handling Medium Supplemented with Chaetoglobosin A | Experimental | Other: Medium Supplemented with Chaetoglobosin A |
| handling Medium as it is. | No intervention | – |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- All ICSI participants agreed
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Medium Supplemented with Chaetoglobosin AA medium with in-house supplementation of Chaetoglobosin A to decrease oocyte degeneration after ICSI and improve the survival rate | Other | Handling Medium Supplemented with Chaetoglobosin A |
Primary outcome
Oocyte Survival after ICSI
Time frame: two days
Survived oocytes per MII injected
7 secondary outcomes
Fertilization rate
Time frame: 6 days of culture
Rate of top-quality embryo
Time frame: 6 days of culture
blastocyst formation and quality
Time frame: 6 days of culture
blastocyst utilization rate
Time frame: 6 days of culture
clinical pregnancy rate
Time frame: 7 weeks
Implantation rate
Time frame: 7 weeks
Ongoing pregnancy rate
Time frame: 12 weeks
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 7 May 2019.
- Individual participant dataSharing planned: No
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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 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medium Supplemented with Chaetoglobosin A in people with Infertility, run by Ibn Sina Hospital at 3 sites 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: finished, as of the sponsor's last update on 7 May 2019. 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. 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?
Oocyte Survival after ICSI (time frame: two days). 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 7 May 2019.