Clinical trial NCT02896777: Triple-arm pH Comparison
Official title: Triple-arm Trial of pH (Tri-pH) Effect on Live Birth After ICSI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: In Vitro Fertilisation Outcome
Keywords: pH
IVF
live birth rate
Lead sponsor: Ibn Sina Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Egyptian IVF Center
name: Banon IVF Center Assiut, Egypt
First posted: 2016-09-12
Enrollment: 2273
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

1. Women age of ≥ 18 to ≤ 40
2. 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).
3. Normal responder (≥ 10 antral follicle count (AFC) during basal ultrasound examination)
4. PCOS
5. Women who have ≥ 1 year of primary or secondary infertility
6. Tubal factor (unilateral, bilateral obstruction or salpingectomy)
7. Normal semen parameters
8. Male factor: oligoasthenozoospermia or obstructive azoospermia
9. Women who are undergoing their first IVF or ICSI cycle or second IVF Cycle with previous successful attempt
10. Women who will undergo only fresh embryo transfer
11. Women who have normal endometrial thickness (\> 7 mm) and echo-pattern at the time of hCG trigger
12. 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:

1. Women who had unilateral oophorectomy
2. Women who had uterine pathology or abnormality
3. Women or their husbands who had abnormal karyotyping
4. Women with history of recurrent abortions or repeated implantation failures
5. Women who had uncontrolled diabetes
6. Women with diagnosed or undiagnosed liver or renal disease
7. Women who had a history of severe ovarian hyperstimulation
8. Women who had history of malignancy or borderline pathology
9. Women who will not meet the inclusion criteria
10. Women who will refuse to participate in the study
11. Women with endometriosis
12. Patient undergoing PGS or PGD
13. Severe male factor and non-obstructive azoospermia.

Primary outcomes:
measure: live-birth rate
timeFrame: > 20 weeks of gestation
Secondary outcomes:
measure: Biochemical pregnancy rate
timeFrame: within 7 weeks of gestation
measure: Clinical pregnancy rate
timeFrame: ≥ 7 weeks of gestation
measure: Ongoing pregnancy rate
timeFrame: within 24 weeks of pregnancy
measure: Miscarriage rate
timeFrame: within 42 weeks of pregnancy
measure: Term Live birth rate
timeFrame: ≥ 37 weeks of gestation
measure: Live-birth-implantation rate
timeFrame: within 42 weeks of gestation
measure: Cumulative live birth after one fresh and one frozen transfer
timeFrame: within one year from randomization
measure: Preterm Birth rate
timeFrame: <37 weeks of gestation
measure: Very preterm birth rate
timeFrame: <32 weeks of gestation
measure: Still birth
timeFrame: 42 weeks after ICSI
measure: Low birth weight babies
timeFrame: 24 hours after delivery
measure: Congenital malformation
timeFrame: within 42 weeks of gestation
measure: Fertilisation rate
timeFrame: Within 18 hours of inseminating the oocyte
measure: Cleavage rate
timeFrame: Within 72 hours of inseminating the oocytes
measure: High quality embryo on day 3
timeFrame: Within 72 hours of inseminating the oocytes
measure: Blastocyst formation rate on day 5/6
timeFrame: Within 5-7 days of inseminating the oocytes
measure: High-quality blastocyst rate on day 5
timeFrame: 5 Days of inseminating the oocytes
measure: Cryopreservation rate on day 5/6
timeFrame: 5-7 Days of inseminating the oocytes
measure: Embryo utilization rate
timeFrame: 5-7 days post ICSI
measure: Top-quality embryo utilization rate
timeFrame: 5-7 days post ICSI
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Banon Assiut
city: Cairo
country: Egypt
facility: Egyptian IVF-ET Center
city: Mansoura
country: Egypt
facility: Royal Centre
city: Qena
country: Egypt
facility: Qena Fertility Center
city: Sohag
country: Egypt
facility: Amshaj
city: Sohag
country: Egypt
facility: IbnSina IVF Center
Study officials:
affiliation: Ibnsina Hospital
name: Mohamed Fawzy
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.