In Vitro Fertilisation OutcomeTri-pHNCT02896777
Triple-arm pH Comparison
A study testing Transfer embryo from pH 7.20±0.02 on either Day 3 or day 5/6, Transfer embryo from pH 7.3±0.02 either Day 3 or day 5/6 and Transfer embryo from pH of 7.4±0.02 on either Day 3 or day 5/6 in people with In Vitro Fertilisation Outcome, run by Ibn Sina Hospital at 6 sites in Egypt.
Trial summary
The culturing human embryo in vitro is a process of myriad contributing elements. From these factors is the pH of embryo culture media, which is crucial for embryo development. The investigators plan to examine three different pH values of the culture media on the live birth rate of in vitro cultured human embryos. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- In Vitro Fertilisation Outcome
- What is being tested?
- Transfer embryo from pH 7.20±0.02 on either Day 3 or day 5/6, Transfer embryo from pH 7.3±0.02 either Day 3 or day 5/6 and Transfer embryo from pH of 7.4±0.02 on either Day 3 or day 5/6
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,273 participants
- Where
- 6 sitesEgypt
- Study dates
- 13 Jun 2020to 11 Aug 2023
- 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
- Women age of ≥ 18 to ≤ 40
- BMI of ≤ 35 (After approval of the DMC on 19 Feb 2021 and the IRB thereafter, BMI is changed from ≤31 to ≤35 based on clinician request. DMC).
- Normal responder (≥ 10 antral follicle count (AFC) during basal ultrasound examination)
- PCOS
- Women who have ≥ 1 year of primary or secondary infertility
- Tubal factor (unilateral, bilateral obstruction or salpingectomy)
Show all 12Show fewer
- Normal semen parameters
- Male factor: oligoasthenozoospermia or obstructive azoospermia
- Women who are undergoing their first IVF or ICSI cycle or second IVF Cycle with previous successful attempt
- Women who will undergo only fresh embryo transfer
- Women who have normal endometrial thickness (> 7 mm) and echo-pattern at the time of hCG trigger
- Women who have normal transvaginal ultrasound during the follicular phase (defined as no intra cavity pathology; e.g. submucousal myomas, polyps or septa)
Who cannot join
- Women who had unilateral oophorectomy
- Women who had uterine pathology or abnormality
- Women or their husbands who had abnormal karyotyping
- Women with history of recurrent abortions or repeated implantation failures
- Women who had uncontrolled diabetes
- Women with diagnosed or undiagnosed liver or renal disease
Show all 13Show fewer
- Women who had a history of severe ovarian hyperstimulation
- Women who had history of malignancy or borderline pathology
- Women who will not meet the inclusion criteria
- Women who will refuse to participate in the study
- Women with endometriosis
- Patient undergoing PGS or PGD
- Severe male factor and non-obstructive azoospermia.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Egypt6 sites
Royal Centre
Al Mansurah, 123456
Banon Assiut
Asyut
Egyptian IVF-ET Center
Cairo
Qena Fertility Center
Qina, Qena Governorate, 123456
Amshaj
Sohag, 12345
IbnSina IVF Center
Sohag
About this study
Official title: Triple-arm Trial of pH (Tri-pH) Effect on Live Birth After ICSI
The culturing human embryo in vitro is a process of myriad contributing elements. From these factors is the pH of embryo culture media, which is crucial for embryo development. The investigators plan to examine three different pH values of the culture media on the live birth rate of in vitro cultured human embryos.
Read the detailed description
In vitro fertilisation laboratory is the black box in which early human embryo development of infertile couple occurs. This laboratory holds many variables such as incubator type, air quality, brands of culture media, culture temperature and the pH of culture medium. Despite the importance of the culture medium pH, there is no single RCT has examined its effect on live birth rate post in vitro fertilisation. The investigators of this study believe that leaving this crucial element to the wishes of large companies and media designers is unwise. This RCT aims to provide a conclusive answer on pH effect on live birth rate of in vitro cultured human embryos.
- Conditions
- In Vitro Fertilisation Outcome
- Being tested
- Transfer embryo from pH 7.20±0.02 on either Day 3 or day 5/6, Transfer embryo from pH 7.3±0.02 either Day 3 or day 5/6, Transfer embryo from pH of 7.4±0.02 on either Day 3 or day 5/6
- Keywords
- pH, IVF, live birth rate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transfer embryo from pH 7.20±0.02 on either Day 3 or day 5/6Other
Post IVF/ICSI and according to the result of the randomization process, women will receive embryo from their oocytes that will be cultured in pH of 7.20±0.02.
Transfer embryo from pH 7.3±0.02 either Day 3 or day 5/6Other
Post IVF/ICSI and according to the result of the randomization process, women will receive embryo from their oocytes that will be cultured in pH of 7.3±0.02.
Transfer embryo from pH of 7.4±0.02 on either Day 3 or day 5/6Other
Post IVF/ICSI and according to the result of the randomization process, women will receive embryo from their oocytes that will be cultured in pH of 7.4±0.02 from day 0 to 5/6
| Study group | Role | What they receive |
|---|---|---|
| Transfer embryos from 7.20±0.02 pH | Experimental | In this arm, the intervention is to culture the inseminated oocytes in vitro in a pH of 7.2±0.02 from day 0 to 5/6 post IVF/ICSI. Then according to the result of the randomization, women will receive their embryos that will be cultured in this pH on either Day 3 or Day 5/6 post IVF/ICSI. Receives: Other: Transfer embryo from pH 7.20±0.02 on either Day 3 or day 5/6 |
| Transfer embryos from 7.3±0.02 pH | Experimental | In this arm, the intervention is to culture the inseminated oocytes in vitro in a pH of 7.3±0.02 from day 0 to 5/6 post IVF/ICSI. Then according to the result of the randomization, women will receive their embryos that will be cultured in this pH on either Day 3 or Day 5/6 post IVF/ICSI. Receives: Other: Transfer embryo from pH 7.3±0.02 either Day 3 or day 5/6 |
| Transfer embryo from 7.4±0.02 | Experimental | In this arm, the intervention is to culture the inseminated oocytes in vitro in a pH of 7.4±0.02 from day 0 to 5/6 post IVF/ICSI. Then according to the result of the randomization, women will receive their embryos that will be cultured in this pH on either Day 3 or Day 5/6 post IVF/ICSI. Receives: Other: Transfer embryo from pH of 7.4±0.02 on either Day 3 or day 5/6 |
What is being measured
The primary outcome is the main question the study is designed to answer.
live-birth rate
delivery of one or more viable infants > 20 weeks of gestation
Measured: > 20 weeks of gestation
Secondary outcomes (20)
Biochemical pregnancy rate
registered positive hCG ≥14 days after egg collection
Measured: within 7 weeks of gestation
Clinical pregnancy rate
presence of a foetal sac with a foetal heart beat on ultrasound > 7 weeks of presence of a foetal sac with a foetal heart beat on ultrasound > 7 weeks of gestation
Measured: ≥ 7 weeks of gestation
Ongoing pregnancy rate
Continued pregnancy after 20 weeks of gestation
Measured: within 24 weeks of pregnancy
Miscarriage rate
Loss of pregnancy before week 20 of gestation
Measured: within 42 weeks of pregnancy
Term Live birth rate
Delivery of one or more viable infants ≥ 37 weeks of gestation
Measured: ≥ 37 weeks of gestation
Live-birth-implantation rate
Number of viable neonates per number of embryos transferred
Measured: within 42 weeks of gestation
Cumulative live birth after one fresh and one frozen transfer
Registered live birth from one fresh and one frozen cycles
Measured: within one year from randomization
Preterm Birth rate
Delivery of one or more viable infants <37 weeks of gestation
Measured: <37 weeks of gestation
Very preterm birth rate
Delivery of one or more viable infants <32 weeks of gestation
Measured: <32 weeks of gestation
Still birth
delivery of nonviable babies > 20 weeks of gestation
Measured: 42 weeks after ICSI
Low birth weight babies
Viable neonate < 2500 gm within 24 hours of delivery
Measured: 24 hours after delivery
Congenital malformation
delivery of congenitally malformed babies
Measured: within 42 weeks of gestation
Fertilisation rate
Presence of 2 pronuclei17±1 hr post insemination/ICSI
Measured: Within 18 hours of inseminating the oocyte
Cleavage rate
registered divided embryo per fertilised oocyte
Measured: Within 72 hours of inseminating the oocytes
High quality embryo on day 3
embryo of 7 or more appropriate-size blastomeres with < 10 fragmentation by volume per Istanbul Consensus
Measured: Within 72 hours of inseminating the oocytes
Blastocyst formation rate on day 5/6
Formed blastocyst of any grade on day 5 or 6 per fertilized oocyte
Measured: Within 5-7 days of inseminating the oocytes
High-quality blastocyst rate on day 5
Blastocyst of ≥ 3.1.1.grading per Istanbul Consensus on day 5
Measured: 5 Days of inseminating the oocytes
Cryopreservation rate on day 5/6
Number of cryopreserved blastocyst on day 5 and 6 per fertilized oocyte
Measured: 5-7 Days of inseminating the oocytes
Embryo utilization rate
Embryo Utilization rate (number of cryopreserved embryos added to the transferred embryos per fertilized oocytes
Measured: 5-7 days post ICSI
Top-quality embryo utilization rate
number of cryopreserved embryos added to the transferred embryos per fertilized oocytes
Measured: 5-7 days post ICSI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2016 (estimated)
- Study start13 Jun 2020
- Primary completion27 Apr 2023
- Study completion11 Aug 2023
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 In Vitro Fertilisation OutcomeStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 2,273 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ibn Sina Hospital
- Sponsor type
- Other government
- Collaborators
- Egyptian IVF Center, Banon IVF Center Assiut, Egypt
- Responsible party
- Principal investigator, Muhammad Fawzy, Ibn Sina Hospital
- Investigators
- Mohamed Fawzy, Principal investigator, Ibnsina Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02896777
- Sponsor's protocol ID
- pH Study
- Acronym
- Tri-pH
- Status last verified
- Aug 2023
- First submitted
- 31 Aug 2016
- Last updated
- 21 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fawzy M, Emad M, Wilkinson J, Mansour R, Mahran A, Fetih A, Abdelrahman M, AbdelGhafar H. Triple-arm trial of pH (Tri-pH) effect on live birth after ICSI in Egyptian IVF facilities: protocol of a randomised controlled trial. BMJ Open. 2020 Feb 4;10(2):e034194. doi: 10.1136/bmjopen-2019-034194.
PubMed 32024790
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Triple-arm Trial of pH (Tri-pH) Effect on Live Birth After ICSI
- ClinicalTrials.gov ID
- NCT02896777
- Acronym / sponsor ID
- Tri-pH / pH Study
- Conditions
- In Vitro Fertilisation Outcome
- Keywords
- pH, IVF, live birth rate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,273 participants (actual)
- Lead sponsor
- Ibn Sina HospitalOther government
- Collaborators
- Egyptian IVF Center, Banon IVF Center Assiut, Egypt
- Study start
- 13 Jun 2020 (actual)
- Primary completion
- 27 Apr 2023 (actual)
- Study completion
- 11 Aug 2023 (actual)
- First posted
- 12 Sep 2016 (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.
The culturing human embryo in vitro is a process of myriad contributing elements. From these factors is the pH of embryo culture media, which is crucial for embryo development. The investigators plan to examine three different pH values of the culture media on the live birth rate of in vitro cultured human embryos.
Detailed description
In vitro fertilisation laboratory is the black box in which early human embryo development of infertile couple occurs. This laboratory holds many variables such as incubator type, air quality, brands of culture media, culture temperature and the pH of culture medium. Despite the importance of the culture medium pH, there is no single RCT has examined its effect on live birth rate post in vitro fertilisation. The investigators of this study believe that leaving this crucial element to the wishes of large companies and media designers is unwise. This RCT aims to provide a conclusive answer on pH effect on live birth rate of in vitro cultured human embryos.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Transfer embryos from 7.20±0.02 pH | Experimental | Other: Transfer embryo from pH 7.20±0.02 on either Day 3 or day 5/6In this arm, the intervention is to culture the inseminated oocytes in vitro in a pH of 7.2±0.02 from day 0 to 5/6 post IVF/ICSI. Then according to the result of the randomization, women will receive their embryos that will be cultured in this pH on either Day 3 or Day 5/6 post IVF/ICSI. |
| Transfer embryos from 7.3±0.02 pH | Experimental | Other: Transfer embryo from pH 7.3±0.02 either Day 3 or day 5/6In this arm, the intervention is to culture the inseminated oocytes in vitro in a pH of 7.3±0.02 from day 0 to 5/6 post IVF/ICSI. Then according to the result of the randomization, women will receive their embryos that will be cultured in this pH on either Day 3 or Day 5/6 post IVF/ICSI. |
| Transfer embryo from 7.4±0.02 | Experimental | Other: Transfer embryo from pH of 7.4±0.02 on either Day 3 or day 5/6In this arm, the intervention is to culture the inseminated oocytes in vitro in a pH of 7.4±0.02 from day 0 to 5/6 post IVF/ICSI. Then according to the result of the randomization, women will receive their embryos that will be cultured in this pH on either Day 3 or Day 5/6 post IVF/ICSI. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Women age of ≥ 18 to ≤ 40
- BMI of ≤ 35 (After approval of the DMC on 19 Feb 2021 and the IRB thereafter, BMI is changed from ≤31 to ≤35 based on clinician request. DMC).
- Normal responder (≥ 10 antral follicle count (AFC) during basal ultrasound examination)
- PCOS
- Women who have ≥ 1 year of primary or secondary infertility
Key exclusion criteria (13 listed)
- Women who had unilateral oophorectomy
- Women who had uterine pathology or abnormality
- Women or their husbands who had abnormal karyotyping
- Women with history of recurrent abortions or repeated implantation failures
- Women who had uncontrolled diabetes
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 |
|---|---|---|
| Transfer embryo from pH 7.20±0.02 on either Day 3 or day 5/6Post IVF/ICSI and according to the result of the randomization process, women will receive embryo from their oocytes that will be cultured in pH of 7.20±0.02. | Other | Transfer embryos from 7.20±0.02 pH |
| Transfer embryo from pH 7.3±0.02 either Day 3 or day 5/6Post IVF/ICSI and according to the result of the randomization process, women will receive embryo from their oocytes that will be cultured in pH of 7.3±0.02. | Other | Transfer embryos from 7.3±0.02 pH |
| Transfer embryo from pH of 7.4±0.02 on either Day 3 or day 5/6Post IVF/ICSI and according to the result of the randomization process, women will receive embryo from their oocytes that will be cultured in pH of 7.4±0.02 from day 0 to 5/6 | Other | Transfer embryo from 7.4±0.02 |
Primary outcome
live-birth rate
Time frame: > 20 weeks of gestation
delivery of one or more viable infants > 20 weeks of gestation
20 secondary outcomes
Biochemical pregnancy rate
Time frame: within 7 weeks of gestation
Clinical pregnancy rate
Time frame: ≥ 7 weeks of gestation
Ongoing pregnancy rate
Time frame: within 24 weeks of pregnancy
Miscarriage rate
Time frame: within 42 weeks of pregnancy
Term Live birth rate
Time frame: ≥ 37 weeks of gestation
Live-birth-implantation rate
Time frame: within 42 weeks of gestation
Cumulative live birth after one fresh and one frozen transfer
Time frame: within one year from randomization
Preterm Birth rate
Time frame: <37 weeks of gestation
Very preterm birth rate
Time frame: <32 weeks of gestation
Still birth
Time frame: 42 weeks after ICSI
Low birth weight babies
Time frame: 24 hours after delivery
Congenital malformation
Time frame: within 42 weeks of gestation
Fertilisation rate
Time frame: Within 18 hours of inseminating the oocyte
Cleavage rate
Time frame: Within 72 hours of inseminating the oocytes
High quality embryo on day 3
Time frame: Within 72 hours of inseminating the oocytes
Blastocyst formation rate on day 5/6
Time frame: Within 5-7 days of inseminating the oocytes
High-quality blastocyst rate on day 5
Time frame: 5 Days of inseminating the oocytes
Cryopreservation rate on day 5/6
Time frame: 5-7 Days of inseminating the oocytes
Embryo utilization rate
Time frame: 5-7 days post ICSI
Top-quality embryo utilization rate
Time frame: 5-7 days post ICSI
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 21 Aug 2023.
- Derived from this study: PubMed 32024790Fawzy M, Emad M, Wilkinson J, Mansour R, Mahran A, Fetih A, Abdelrahman M, AbdelGhafar H. Triple-arm trial of pH (Tri-pH) effect on live birth after ICSI in Egyptian IVF facilities: protocol of a randomised controlled trial. BMJ Open. 2020 Feb 4;10(2):e034194. doi: 10.1136/bmjopen-2019-034194.
- 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.
Mohamed Fawzy principal investigator
Ibnsina Hospital
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transfer embryo from pH 7.20±0.02 on either Day 3 or day 5/6, Transfer embryo from pH 7.3±0.02 either Day 3 or day 5/6 and Transfer embryo from pH of 7.4±0.02 on either Day 3 or day 5/6 in people with In Vitro Fertilisation Outcome, run by Ibn Sina Hospital at 6 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 12 inclusion and 13 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 21 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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: > 20 weeks of gestation). 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 NCT02896777, 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 21 Aug 2023.