Triple-arm Trial of pH (Tri-pH) Effect on Live Birth After ICSI
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,273
- 试验地点
- 10
- 主要终点
- live-birth rate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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)
- •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)
排除标准
- •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.
结局指标
主要结局
live-birth rate
时间窗: > 20 weeks of gestation
delivery of one or more viable infants \> 20 weeks of gestation
次要结局
- Low birth weight babies(24 hours after delivery)
- Miscarriage rate(within 42 weeks of pregnancy)
- Term Live birth rate(≥ 37 weeks of gestation)
- Still birth(42 weeks after ICSI)
- High-quality blastocyst rate on day 5(5 Days of inseminating the oocytes)
- Clinical pregnancy rate(≥ 7 weeks of gestation)
- Very preterm birth rate(<32 weeks of gestation)
- High quality embryo on day 3(Within 72 hours of inseminating the oocytes)
- Embryo utilization rate(5-7 days post ICSI)
- Live-birth-implantation rate(within 42 weeks of gestation)
- Fertilisation rate(Within 18 hours of inseminating the oocyte)
- Blastocyst formation rate on day 5/6(Within 5-7 days of inseminating the oocytes)
- Biochemical pregnancy rate(within 7 weeks of gestation)
- Ongoing pregnancy rate(within 24 weeks of pregnancy)
- Cumulative live birth after one fresh and one frozen transfer(within one year from randomization)
- Preterm Birth rate(<37 weeks of gestation)
- Cleavage rate(Within 72 hours of inseminating the oocytes)
- Congenital malformation(within 42 weeks of gestation)
- Top-quality embryo utilization rate(5-7 days post ICSI)
- Cryopreservation rate on day 5/6(5-7 Days of inseminating the oocytes)
研究者
Muhammad Fawzy
IVF Lab Director
Ibn Sina Hospital