InfertilityNCT03778866
Comparing HEPES-buffered With Bicarbonate-buffered as Handling Media During the ICSI Procedure on Live Birth Rate
A study testing Bicarbonate-buffered handling medium in people with Infertility, run by Muhammad Fawzy at 3 sites in Egypt.
Trial summary
The pH stability during human gamete handling for intracytoplasmic sperm injection (ICSI) is physiologically sound. As the pH change for bicarbonate-buffered medium, scientists assumed whether the use of HEPES or MOPS buffered medium would provide more stable pH, thereby better outcomes. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Bicarbonate-buffered handling medium
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,057 participants
- Where
- 3 sitesEgypt
- Study dates
- 15 Jan 2019to 5 Aug 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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- ICSI indicated cycles
Who cannot join
- severe medical illness
Trial locations and contacts
3 sites in 1 country.
Egypt3 sites
Banon Assiut
Asyut
Qena Fertility Center
Qina, Qena Governorate, 123456
IbnSina IVF Center
Sohag
About this study
Official title: Whether the Use of HEPES-buffered Medium Would Affect Live Birth Rate After ICSI
The pH stability during human gamete handling for intracytoplasmic sperm injection (ICSI) is physiologically sound. As the pH change for bicarbonate-buffered medium, scientists assumed whether the use of HEPES or MOPS buffered medium would provide more stable pH, thereby better outcomes. However, the oil use and time frame outside the incubators have not been accounted for. This study is to evaluate the use of HEPES buffered medium compared with the bicarbonate-buffered medium on ICSI outcomes.
- Conditions
- Infertility
- Being tested
- Bicarbonate-buffered handling medium
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bicarbonate-buffered handling mediumOther
The investigators will evaluate whether the usual bicarbonate culture medium can replace the HEPES buffered medium effectively.
| Study group | Role | What they receive |
|---|---|---|
| Bicarbonate-buffered Medium | Experimental | Not described Receives: Other: Bicarbonate-buffered handling medium |
| HEPES-MOPS-buffered Medium | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
live birth rate
viable neonate after 30 weeks of Gestation
Measured: 40 weeks
Secondary outcomes (4)
Clinical pregnancy rate
a positive heartbeat on ultrasound at ≥ 7 weeks of gestation
Measured: 12 weeks
biochemical pregnancy rate
positive b-hCG at ≥ 14 days following embryo transfer
Measured: two weeks
embryo developmental rates
fertilized oocyte per injected ones and developed embryos per fertilized oocytes
Measured: 6 days of culture
Ongoing pregnancy rate
Continued pregnancy after week 12 of gestation
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2018
- Study start15 Jan 2019
- Primary completion5 Aug 2019
- Study completion5 Aug 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, Investigator, Outcomes assessor
- Enrolment
- 1,057 participants (actual)
Sponsor and investigators
- Lead sponsor
- Muhammad Fawzy
- Sponsor type
- Other government
- Collaborators
- Banoon IVF Center, Quena IVF Center
- Responsible party
- Sponsor-investigator, Muhammad Fawzy, Ibn Sina Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03778866
- Sponsor's protocol ID
- IbnSina-HEPES
- Status last verified
- Aug 2019
- First submitted
- 15 Dec 2018
- Last updated
- 7 Aug 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 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Whether the Use of HEPES-buffered Medium Would Affect Live Birth Rate After ICSI
- ClinicalTrials.gov ID
- NCT03778866
- Acronym / sponsor ID
- IbnSina-HEPES
- Conditions
- Infertility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,057 participants (actual)
- Lead sponsor
- Muhammad FawzyOther government
- Collaborators
- Banoon IVF Center, Quena IVF Center
- Study start
- 15 Jan 2019 (actual)
- Primary completion
- 5 Aug 2019 (actual)
- Study completion
- 5 Aug 2019 (actual)
- First posted
- 19 Dec 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.
The pH stability during human gamete handling for intracytoplasmic sperm injection (ICSI) is physiologically sound. As the pH change for bicarbonate-buffered medium, scientists assumed whether the use of HEPES or MOPS buffered medium would provide more stable pH, thereby better outcomes. However, the oil use and time frame outside the incubators have not been accounted for. This study is to evaluate the use of HEPES buffered medium compared with the bicarbonate-buffered medium on ICSI outcomes.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bicarbonate-buffered Medium | Experimental | Other: Bicarbonate-buffered handling medium |
| HEPES-MOPS-buffered Medium | No intervention | – |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- ICSI indicated cycles
Key exclusion criteria (1 listed)
- severe medical illness
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 |
|---|---|---|
| Bicarbonate-buffered handling mediumThe investigators will evaluate whether the usual bicarbonate culture medium can replace the HEPES buffered medium effectively. | Other | Bicarbonate-buffered Medium |
Primary outcome
live birth rate
Time frame: 40 weeks
viable neonate after 30 weeks of Gestation
4 secondary outcomes
Clinical pregnancy rate
Time frame: 12 weeks
biochemical pregnancy rate
Time frame: two weeks
embryo developmental rates
Time frame: 6 days of culture
Ongoing pregnancy rate
Time frame: 16 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 Aug 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 Bicarbonate-buffered handling medium in people with Infertility, run by Muhammad Fawzy 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 Aug 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?
live birth rate (time frame: 40 weeks). 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 Aug 2019.