InfertilityNCT03641014
Whether Using Sequential pH Would Improve Human Blastocyst Formation
A study testing pH Effect on blastocyst formation in people with Infertility, run by Ibn Sina Hospital at 3 sites in Egypt.
Trial summary
Any drift in extracellular pH (pHe) from the intercellular pH (pHi) could alter the mechanism regulating transporters and exchangers through the plasma membrane. This could lead to difficulty in restoring the physiological level of pHi. 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?
- pH Effect on blastocyst formation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,312 participants
- Where
- 3 sitesEgypt
- Study dates
- 28 Aug 2018to 10 Jun 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 cycles
Who cannot join
- No exclusion
Trial locations and contacts
3 sites in 1 country.
Egypt3 sites
Banon Assiut
Asyut
Quena IVF Centre
Quena, Qena Governorate, 12346
IbnSina IVF Center, IbnSina Hospital
Sohag, 12345
About this study
Official title: Sequential pH Effect on Blastocyst Formation Rate
Any drift in extracellular pH (pHe) from the intercellular pH (pHi) could alter the mechanism regulating transporters and exchangers through the plasma membrane. This could lead to difficulty in restoring the physiological level of pHi. The critical stages that lack robust mechanism of regulating the pHi are the denuded oocyte, early stage of fertilization or a thawed embryo. This, in turn, could lead to a significant effect of the perturbations on embryo development. Convincing evidence regarding the optimal pHe for culturing human embryo is, so far, scanty and mostly anecdotal. The embryo has been reported to have a compensatory mechanism to grow at pHe between 7.0-7.4. Others have recommended that embryo need a sequential pH to viably grow suggesting that the post-genomic activation stage needs a slightly alkaline range of pH. However, whether this holds true remains to be examined.
- Conditions
- Infertility
- Being tested
- pH Effect on blastocyst formation
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pH Effect on blastocyst formationOther
to investigate which pH is suitable for each stage of embryo development
| Study group | Role | What they receive |
|---|---|---|
| Sequential pH culture (7.23 then 7.35) | Experimental | A split embryo at day 3 to continue culture at a pHe of 7.23±0.02 or to be cultured at a pH of 7.35±0.02 and monitor the effect on blastocyst development. Receives: Other: pH Effect on blastocyst formation |
| Continuously pH culture at 7.23 | No intervention | Embryo culture from day 0 to 5 or 6 at 7.23 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ongoing Pregnancy rate
women with continued pregnancy at week 12 of gestation
Measured: 12 weeks
Secondary outcomes (4)
rate of usable blastocysts
number of blastocysts suitable for transfer on day 5 or 6
Measured: 6 days of culture
Blastocyst formation rate
number of formed blastocyst per Fertilized oocyte
Measured: 6 days of culture
Clinical pregnancy rate
number of women with ultrasound detection of sacs with heartbeat per stimulated cycle
Measured: 3 months
Implantation rate
number of sacs with a heartbeat
Measured: 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2018
- Study start28 Aug 2018
- Primary completion30 May 2019
- Study completion10 Jun 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, Outcomes assessor
- Enrolment
- 1,312 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ibn Sina Hospital
- Sponsor type
- Other government
- Collaborators
- Banoon IVF Center, Quena IVF Centre
- Responsible party
- Principal investigator, Muhammad Fawzy, Ibn Sina Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03641014
- Sponsor's protocol ID
- IbnSina-Sequential pH
- Status last verified
- Jul 2019
- First submitted
- 10 Aug 2018
- Last updated
- 16 Jul 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 16 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sequential pH Effect on Blastocyst Formation Rate
- ClinicalTrials.gov ID
- NCT03641014
- Acronym / sponsor ID
- IbnSina-Sequential pH
- Conditions
- Infertility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,312 participants (actual)
- Lead sponsor
- Ibn Sina HospitalOther government
- Collaborators
- Banoon IVF Center, Quena IVF Centre
- Study start
- 28 Aug 2018 (actual)
- Primary completion
- 30 May 2019 (actual)
- Study completion
- 10 Jun 2019 (actual)
- First posted
- 21 Aug 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.
Any drift in extracellular pH (pHe) from the intercellular pH (pHi) could alter the mechanism regulating transporters and exchangers through the plasma membrane. This could lead to difficulty in restoring the physiological level of pHi. The critical stages that lack robust mechanism of regulating the pHi are the denuded oocyte, early stage of fertilization or a thawed embryo. This, in turn, could lead to a significant effect of the perturbations on embryo development. Convincing evidence regarding the optimal pHe for culturing human embryo is, so far, scanty and mostly anecdotal. The embryo has been reported to have a compensatory mechanism to grow at pHe between 7.0-7.4. Others have recommended that embryo need a sequential pH to viably grow suggesting that the post-genomic activation stage needs a slightly alkaline range of pH. However, whether this holds true remains to be examined.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequential pH culture (7.23 then 7.35) | Experimental | Other: pH Effect on blastocyst formationA split embryo at day 3 to continue culture at a pHe of 7.23±0.02 or to be cultured at a pH of 7.35±0.02 and monitor the effect on blastocyst development. |
| Continuously pH culture at 7.23 | No intervention | –Embryo culture from day 0 to 5 or 6 at 7.23 |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- ICSI cycles
Key exclusion criteria (1 listed)
- No exclusion
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 |
|---|---|---|
| pH Effect on blastocyst formationto investigate which pH is suitable for each stage of embryo development | Other | Sequential pH culture (7.23 then 7.35) |
Primary outcome
Ongoing Pregnancy rate
Time frame: 12 weeks
women with continued pregnancy at week 12 of gestation
4 secondary outcomes
rate of usable blastocysts
Time frame: 6 days of culture
Blastocyst formation rate
Time frame: 6 days of culture
Clinical pregnancy rate
Time frame: 3 months
Implantation rate
Time frame: 7 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 16 Jul 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 pH Effect on blastocyst formation 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 16 Jul 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?
Ongoing Pregnancy rate (time frame: 12 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 16 Jul 2019; AzTrials last refreshed its copy on 30 Oct 2026.