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Comparing Three Different Ex Vivo pH Levels of Human Embryo Culture on Live Birth (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.
  • Other: Transfer embryo from pH 7.21±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 7.21±0.02.
    • Other: Transfer embryo from pH 7.29±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 7.29±0.02.
      • Other: Transfer embryo that cultured in pH of 7.23±0.02 from Day 0 to Day 3 then in pH of 7.32±0.02
        Post IVF/ICSI and according to the result of the randomization process, women will receive embryo from their oocytes that will be sequentially cultured in pH of in pH of 7.23±0.02 from Day 0 to Day 3 then in pH of 7.32±0.02
        Ages eligible for Study
        18 Years to 40 Years
        Genders eligible for Study
        Female
        Accepts Healthy Volunteers
        No
        Inclusion Criteria:
        • Women age of ≥ 18 to ≤ 40 2) BMI of ≤ 30 3) Normal responder (≥ 10 antral follicle count (AFC) during basal ultrasound examination) 4) PCOS 5) Women who have ≥ 1 years of primary or secondary infertility 6) Tubal factor (unilateral, bilateral obstruction or salpingectomy) 7) Normal or mild to moderate semen parameters 8) Women who are undergoing their first IVF or ICSI cycle 9) Women who will undergo only fresh embryo transfer 10) Women who have previous successful IVF or ICSI cycle 11) Women whose retrieved ≥ 7 mature oocytes 12) Women who have normal endometrial thickness (8-12) and echo-pattern at the time of the hCG trigger 13) Women who have normal transvaginal ultrasound during the follicular phase examination (defined as no intracavitary pathology; e.g. submucous myomas, polyps or septa) I
        Exclusion Criteria:
        • Women who had unilateral oophorectomy
        • Women who had uterine pathology or abnormality
        • Women or their husbands who had abnormal karyotyping
        • Women who had history of recurrent abortion or repeated implantation failure
        • Women who had uncontrolled diabetes
        • Women who had had diagnosed or undiagnosed liver or renal disease
        • Women who had a history of severe ovarian hyperstimulation
        • Women who had history of malignancy or borderline pathology
        • Oligoasthenozoospermia or azoospermia Women who will not meet the inclusion criteria
        • Women who will refuse to participate in the study
        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.

        1 locations

        Egypt (1)
        • IbnSina IVF Center
          not yet recruiting
          Sohag, Egypt
        Status:
        not yet recruiting
        Type:
        Interventional
        Phase:
        -
        Start:
        31 August, 2017
        Updated:
        13 May, 2017
        Participants:
        2000
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