Triple-arm pH Comparison

Ibn Sina Hospital2,273 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

TRIPLE

Enrollment

2,273

Conditions

In Vitro Fertilisation Outcome

Interventions

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

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 5/6OTHER

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 5/6OTHER

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

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 40 Years

Medical Language ↔ Plain English

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.

Locations (6)

Qena Fertility Center

Qina, Qena Governorate, Egypt

Royal Centre

Al Mansurah, Egypt

Banon Assiut

Asyut, Egypt

Egyptian IVF-ET Center

Cairo, Egypt

Amshaj

Outcomes

Primary Outcomes

live-birth rate

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

Time frame: > 20 weeks of gestation

Secondary Outcomes

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

Data from ClinicalTrials.gov

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