An interventional study of Transfer embryo from pH 7.20±0.02 on either Day 3 or day 5/6 and Transfer embryo from pH 7.3±0.02 either Day 3 or day 5/6 in In Vitro Fertilisation Outcome, sponsored by Ibn Sina Hospital. Completed at 6 sites in Egypt. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2023-08-21.
Sponsored by Ibn Sina Hospital · Not applicable, Interventional, and Basic science
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.
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.
Ibn Sina Hospital is the lead sponsor of 28 studies on the registry; none are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Other: Transfer embryo from pH 7.20±0.02 on either Day 3 or day 5/6
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.
Other: Transfer embryo from pH 7.3±0.02 either Day 3 or day 5/6
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.
Other: Transfer embryo from pH of 7.4±0.02 on either Day 3 or day 5/6
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.
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.
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
live-birth rate
delivery of one or more viable infants \> 20 weeks of gestation
Time frame: > 20 weeks of gestation
Biochemical pregnancy rate
registered positive hCG ≥14 days after egg collection
Time frame: 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
Time frame: ≥ 7 weeks of gestation
Ongoing pregnancy rate
Continued pregnancy after 20 weeks of gestation
Time frame: within 24 weeks of pregnancy
Miscarriage rate
Loss of pregnancy before week 20 of gestation
Time frame: within 42 weeks of pregnancy
Term Live birth rate
Delivery of one or more viable infants ≥ 37 weeks of gestation
Time frame: ≥ 37 weeks of gestation
Live-birth-implantation rate
Number of viable neonates per number of embryos transferred
Time frame: 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
Time frame: within one year from randomization
Preterm Birth rate
Delivery of one or more viable infants \<37 weeks of gestation
Time frame: <37 weeks of gestation
Very preterm birth rate
Delivery of one or more viable infants \<32 weeks of gestation
Time frame: <32 weeks of gestation
Still birth
delivery of nonviable babies \> 20 weeks of gestation
Time frame: 42 weeks after ICSI
Low birth weight babies
Viable neonate \< 2500 gm within 24 hours of delivery
Time frame: 24 hours after delivery
Congenital malformation
delivery of congenitally malformed babies
Time frame: within 42 weeks of gestation
Fertilisation rate
Presence of 2 pronuclei17±1 hr post insemination/ICSI
Time frame: Within 18 hours of inseminating the oocyte
Cleavage rate
registered divided embryo per fertilised oocyte
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 5 Days of inseminating the oocytes
Cryopreservation rate on day 5/6
Number of cryopreserved blastocyst on day 5 and 6 per fertilized oocyte
Time frame: 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
Time frame: 5-7 days post ICSI
Top-quality embryo utilization rate
number of cryopreserved embryos added to the transferred embryos per fertilized oocytes
Time frame: 5-7 days post ICSI
Plan to share: No
Ran from Jun 2020 to primary completion in Apr 2023, 34 months.
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This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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Ibn Sina Hospital