The Effect of Constant 5% Versus Gradient 8%, 5%, 2% Oxygen Concentration on the Development of Sibling Human Embryos in Vitro
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Proportion of Inseminated Oocytes Developed to the Morphologically Optimal Blastocysts on Day 5
研究概览
简要总结
The purpose of this study is to investigate the development of human embryos in vitro under two different oxygen concentrations; a static 5% during all five days of culture or under an oxygen gradient, starting with 8% from day-0 to day-3, continuing with 5% on day-3 and following with 2% of oxygen from the end of day-3 to day-5.
详细描述
Several studies have shown that embryonic morphological parameters improved when the oxygen concentration in embryo culture was reduced from 20% to 5%. Early mammalian embryos developed faster, had shorter cell cycles, a higher blastocyst formation rate and a better integrity of the inner cell mass (ICM) compared to embryos cultured at 20% oxygen concentration.
Recent studies have shown that the oxygen concentration in the female reproductive tract is not static. In the fallopian tubes of higher mammals it is at around 8%, while in the uterus, at the time of embryo implantation, the oxygen concentration is almost anoxic (2%).
Mimicking such physiological conditions that better reflect the in vivo environment in the human reproductive tract is the goal of assisted reproductive technology (ART).
The aim of this study is to assess whether changing the static 5% oxygen during five days of in vitro embryo culture to the gradient of oxygen, starting with 8% from day-0 to day-3, continuing with 5% on day-3 and following with 2% of oxygen from the end of day-3 to day-5, better reflects conditions found within the human reproductive tract and improves embryo developmental characteristics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Investigator)
盲法说明
The cohort of oocyte-cumulus complexes will be divided into either the study or control group by simple randomization. All embryologists involved in the study will be blinded during embryo assessment, measurement, and selection for embryo transfer or vitrification. A code system will be used on the Petri dishes to ensure the embryologists are blinded.
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age of women between 18 and 35 years.
- •Body mass index (BMI) between 18 and 30 kg/m².
- •Only patients with ICSI procedure (male factor of infertility, excluding azoospermia) and blastocyst culture.
- •Patients from first and second ICSI cycle attempt.
- •Gonadotropin hormone-releasing hormone (GnRH) antagonist cycles.
排除标准
- •Presence of endometriosis.
- •Previous clinical intervention on ovaries.
- •Connected endocrine or metabolic diseases.
- •Presence of polycystic ovary syndrome.
结局指标
主要结局
Proportion of Inseminated Oocytes Developed to the Morphologically Optimal Blastocysts on Day 5
时间窗: Embryos will be annotated on day 5 post insemination (at 8:00 am).
The primary outcome measure will be the proportion of oocytes that will develop to the morphologically optimal day-5 blastocysts, scored 4-5AA according to Gardner criteria. According to the scoring system of Gardner, blastocyst morphology parameters such as the degree of blastocoel expansion (1-5), the morphological appearance of the inner cell mass (ICM) (A, B, C) and the cohesiveness of trophectoderm (TE) (A, B, C) will be measured.
次要结局
- Measured Times From Insemination to Different Embryonic Stages Reached(Morphokinetic timings were recorded continuously (every 5 minutes) throughout embryo culture, up to 124 hours (Day 5) post-insemination.)
- Blastocyst and Inner Cell Mass (ICM) Surface Area Measurement on Day 5(Fix time (116 hours) post insemination)
- Number of Trophectoderm Cells on Day 5(Fix time (116 hours) post insemination.)
- Incidence of Atypical Embryo Cleavages(Continuously (a picture will be taken every 5 minutes) during 5 days of embryo culture.)
研究者
Borut Kovačič
Prof. Borut Kovačič, PhD
University Medical Centre Maribor