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Completed

NCT Number: NCT02896777

Triple-arm pH Comparison

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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Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Qena Fertility Center, Qina, Qena Governorate, Egypt

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About this 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)
  • 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)

Exclusion criteria

  • 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
  • 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.

Treatment and study plan

Transfer embryo from pH 7.20±0.02 on either Day 3 or day 5/6

Other

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 5/6

Other

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 5/6

Other

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

Primary outcomes

  1. live-birth rate

    Time frame: > 20 weeks of gestation

    delivery of one or more viable infants > 20 weeks of gestation

Secondary outcomes

  1. Biochemical pregnancy rate

    Time frame: within 7 weeks of gestation

    registered positive hCG ≥14 days after egg collection

  2. Clinical pregnancy rate

    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

  3. Ongoing pregnancy rate

    Time frame: within 24 weeks of pregnancy

    Continued pregnancy after 20 weeks of gestation

  4. Miscarriage rate

    Time frame: within 42 weeks of pregnancy

    Loss of pregnancy before week 20 of gestation

  5. Term Live birth rate

    Time frame: ≥ 37 weeks of gestation

    Delivery of one or more viable infants ≥ 37 weeks of gestation

  6. Live-birth-implantation rate

    Time frame: within 42 weeks of gestation

    Number of viable neonates per number of embryos transferred

  7. Cumulative live birth after one fresh and one frozen transfer

    Time frame: within one year from randomization

    Registered live birth from one fresh and one frozen cycles

  8. Preterm Birth rate

    Time frame: <37 weeks of gestation

    Delivery of one or more viable infants <37 weeks of gestation

  9. Very preterm birth rate

    Time frame: <32 weeks of gestation

    Delivery of one or more viable infants <32 weeks of gestation

  10. Still birth

    Time frame: 42 weeks after ICSI

    delivery of nonviable babies > 20 weeks of gestation

  11. Low birth weight babies

    Time frame: 24 hours after delivery

    Viable neonate < 2500 gm within 24 hours of delivery

  12. Congenital malformation

    Time frame: within 42 weeks of gestation

    delivery of congenitally malformed babies

  13. Fertilisation rate

    Time frame: Within 18 hours of inseminating the oocyte

    Presence of 2 pronuclei17±1 hr post insemination/ICSI

  14. Cleavage rate

    Time frame: Within 72 hours of inseminating the oocytes

    registered divided embryo per fertilised oocyte

  15. High quality embryo on day 3

    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

  16. Blastocyst formation rate on day 5/6

    Time frame: Within 5-7 days of inseminating the oocytes

    Formed blastocyst of any grade on day 5 or 6 per fertilized oocyte

  17. High-quality blastocyst rate on day 5

    Time frame: 5 Days of inseminating the oocytes

    Blastocyst of ≥ 3.1.1.grading per Istanbul Consensus on day 5

  18. Cryopreservation rate on day 5/6

    Time frame: 5-7 Days of inseminating the oocytes

    Number of cryopreserved blastocyst on day 5 and 6 per fertilized oocyte

  19. Embryo utilization rate

    Time frame: 5-7 days post ICSI

    Embryo Utilization rate (number of cryopreserved embryos added to the transferred embryos per fertilized oocytes

  20. Top-quality embryo utilization rate

    Time frame: 5-7 days post ICSI

    number of cryopreserved embryos added to the transferred embryos per fertilized oocytes

Sponsors and collaborators

Lead sponsor

Ibn Sina Hospital

Other Gov

Collaborators

  • Banon IVF Center Assiut, Egypt
  • Egyptian IVF Center

Registry information

Official study title

Triple-arm Trial of pH (Tri-pH) Effect on Live Birth After ICSI

Acronym: Tri-pH

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Sep 12, 2016
Registry last updated
Aug 21, 2023

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.