Effects of Light vs. Heavy Paraffin Oil on Embryo Culture in IVF: A Prospective Study on Development and Pregnancy Rate
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 818
- 试验地点
- 2
- 主要终点
- Fertilization Rate
研究概览
简要总结
This prospective study aims to compare the effects of light and heavy paraffin oil in embryo culture during in vitro fertilization (IVF). Paraffin oil is commonly used in IVF laboratories to protect embryo culture media from evaporation and temperature fluctuations. However, the impact of different oil viscosities on embryo development and pregnancy outcomes remains unclear.
Participants undergoing IVF treatment will have their embryos cultured under either light or heavy paraffin oil conditions. The study will evaluate key outcomes, including embryo development, blastocyst formation rates, and pregnancy rates. Findings from this research may help optimize embryo culture conditions, potentially improving IVF success rates and guiding best laboratory practices.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women undergoing in vitro fertilization (IVF) treatment with planned embryo culture.
- •Patients with normal ovarian function or undergoing ovarian stimulation for IVF.
- •Willingness to participate and provide informed consent.
排除标准
- •Presence of severe uterine abnormalities (e.g., congenital malformations, Asherman's syndrome).
- •History of recurrent implantation failure (≥3 unsuccessful IVF attempts).
- •Poor ovarian response (e.g., ≤3 oocytes retrieved in a previous IVF cycle).
- •Presence of severe male factor infertility, requiring testicular sperm extraction (TESE) or micro-TESE.
- •Use of pre-implantation genetic testing (PGT) for embryo selection.
- •Known autoimmune disorders or uncontrolled chronic conditions (e.g., diabetes, thyroid disorders) that may affect pregnancy outcomes.
- •Participation in another clinical trial that may interfere with study outcomes.
- •Donor cycles or surrogacy.
结局指标
主要结局
Fertilization Rate
时间窗: 16-20 hours post-insemination
The proportion of oocytes that successfully undergo fertilization after insemination, as determined by the presence of two pronuclei (2PN) at the appropriate time post-fertilization.
Cleavage Rate
时间窗: 48 hours post-fertilization
The proportion of fertilized oocytes that progress to cleavage-stage embryos, assessed by the number of embryos that reach at least the two-cell stage within 48 hours after fertilization.
Blastocyst Formation Rate
时间窗: 5-6 days post-fertilization
The proportion of embryos that successfully develop into blastocysts by Day 5 or Day 6 of culture, assessed based on morphological grading criteria.
次要结局
- Clinical Pregnancy Rate(6-7 weeks post-embryo transfer)
- Ongoing Pregnancy Rate(12 weeks post-embryo transfer)
- Live Birth Rate(At delivery (up to ~40 weeks of gestation))
- Positive Beta-hCG(14 days post-embryo transfer)
- Pregnancy Loss Rate(From positive beta-hCG until delivery)
- Implantation Rate(4-5 weeks post-embryo transfer)
研究者
Thi Thanh Thuy Tran, MD
Principal Investigator
Hung Vuong Hospital