Transfer embryo from pH 7.20±0.02 on either Day 3 or day 5/6
OtherPost 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.
NCT Number: NCT02896777
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.
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Notify Me18 year–40 year
Female
Interventional
Not applicable
Qena Fertility Center, Qina, Qena Governorate, Egypt
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: > 20 weeks of gestation
delivery of one or more viable infants > 20 weeks of gestation
Time frame: within 7 weeks of gestation
registered positive hCG ≥14 days after egg collection
Time frame: ≥ 7 weeks of gestation
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: within 24 weeks of pregnancy
Continued pregnancy after 20 weeks of gestation
Time frame: within 42 weeks of pregnancy
Loss of pregnancy before week 20 of gestation
Time frame: ≥ 37 weeks of gestation
Delivery of one or more viable infants ≥ 37 weeks of gestation
Time frame: within 42 weeks of gestation
Number of viable neonates per number of embryos transferred
Time frame: within one year from randomization
Registered live birth from one fresh and one frozen cycles
Time frame: <37 weeks of gestation
Delivery of one or more viable infants <37 weeks of gestation
Time frame: <32 weeks of gestation
Delivery of one or more viable infants <32 weeks of gestation
Time frame: 42 weeks after ICSI
delivery of nonviable babies > 20 weeks of gestation
Time frame: 24 hours after delivery
Viable neonate < 2500 gm within 24 hours of delivery
Time frame: within 42 weeks of gestation
delivery of congenitally malformed babies
Time frame: Within 18 hours of inseminating the oocyte
Presence of 2 pronuclei17±1 hr post insemination/ICSI
Time frame: Within 72 hours of inseminating the oocytes
registered divided embryo per fertilised oocyte
Time frame: Within 72 hours of inseminating the oocytes
embryo of 7 or more appropriate-size blastomeres with < 10 fragmentation by volume per Istanbul Consensus
Time frame: Within 5-7 days of inseminating the oocytes
Formed blastocyst of any grade on day 5 or 6 per fertilized oocyte
Time frame: 5 Days of inseminating the oocytes
Blastocyst of ≥ 3.1.1.grading per Istanbul Consensus on day 5
Time frame: 5-7 Days of inseminating the oocytes
Number of cryopreserved blastocyst on day 5 and 6 per fertilized oocyte
Time frame: 5-7 days post ICSI
Embryo Utilization rate (number of cryopreserved embryos added to the transferred embryos per fertilized oocytes
Time frame: 5-7 days post ICSI
number of cryopreserved embryos added to the transferred embryos per fertilized oocytes
Ibn Sina Hospital
Other Gov
Triple-arm Trial of pH (Tri-pH) Effect on Live Birth After ICSI
Acronym: Tri-pH
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.