A Multicenter Prospective Randomized Controlled Clinical Trial Comparing Constant (5%) Versus Sequential (5%-2%) Oxygen Concentration Embryo Culture Protocols in Assisted Reproductive Technology: Evaluating Term Live Birth and Offspring Health Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 980
- 试验地点
- 6
- 主要终点
- Term live births
研究概览
简要总结
To evaluate whether there were significant differences in the effects of constant (5%) versus sequential (5%-2%) oxygen concentration protocols in embryo culture on term live birth rates.
This study will be conducted in five centers including the Clinical Center of Reproductive Medicine, First Affiliated Hospital of Nanjing Medical Universit. 980 women who wish to undergo blastocyst transplantation will be included in the study.
The study data will be analyzed statistically.
详细描述
While blastocyst transfer has been shown to improve live birth rates, concerns exist regarding potential telomere shortening in offspring, which is associated with premature aging and various health issues. Our previous study further explores the role of oxygen tension in telomere length regulation, identifying hypoxia-inducible factor 1α (Hif1α) degradation as a key factor. Based on these findings, the study proposes a prospective, randomized controlled clinical trial comparing constant (5%) versus sequential (5%-2%) oxygen concentration protocols in embryo culture to assess their impact on term live birth rates and offspring telomere length.
This study will be conducted in five centers including the Clinical Center of Reproductive Medicine, First Affiliated Hospital of Nanjing Medical Universit. 980 women who wish to undergo blastocyst transplantation will be included in the study.
Female infertile patients who consent to blastocyst transfer will be considered for inclusion in the study. Patients will be randomly assigned to a constant (5%) or sequential (5%-2%) oxygen concentration protocols in embryo culture. This study will record live birth rates, perinatal and perinatal complications, and offspring health status of women in both groups of embryo culture regimens to assess the effects of different embryo culture regimens on term live birth rates and offspring health.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female: age ≥20 and ≤40 years, male: age ≥20 and ≤50 years;
- •Proposed 1st or 2nd cycle of IVF or ICSI fertilization;
- •≥ 4 transferable embryos at oocyte stage.
排除标准
- •Diagnosis of abnormal uterine cavity morphology (confirmed by 3D ultrasound or hysteroscopy), including uterine malformations (mediastinal uterus, unicornuate uterus, bicornuate uterus), submucosal uterine fibroids, or uterine adhesions;
- •Patients who are proposed to undergo IVM;
- •Patients who are proposed to undergo PGD/ PGS;
- •Patients with untreated severe hydrosalpinx (confirmed by ultrasound or HSG);
- •Patients with a history of recurrent miscarriage (2 or more previous pregnancy losses, excluding biochemical pregnancies);
- •Patients who plan to freeze whole embryos and are unable to complete a single embryo transfer within six months;
- •Patients with contraindications to assisted reproductive technology and pregnancy, or suffering from diseases that have a definite effect on pregnancy: including uncontrolled hypertension, heart disease with definite symptoms, uncontrolled diabetes, undefined diagnosis of liver or kidney disease or liver or kidney insufficiency, severe anemia, history of previous venous thrombosis, pulmonary embolism or cerebrovascular events, history of malignant tumors, suspected malignant tumors, and undiagnosed abnormal uterine bleeding.
研究组 & 干预措施
Constant (5%) oxygen concentration protocols in embryo culture
Patients randomly assigned to use constant (5%) oxygen concentration protocols in embryo culture
干预措施: Constant oxygen concentration protocols in embryo culture (Procedure)
Sequential (5%-2%) oxygen concentration protocols in embryo culture
Patients randomly assigned to use Sequential (5%-2%) oxygen concentration protocols in embryo culture
干预措施: Sequential oxygen concentration protocols in embryo culture (Procedure)
结局指标
主要结局
Term live births
时间窗: 3 years
Full-term healthy live birth rate for all patients
次要结局
- Clinical pregnancy rate(3 years)
- Ectopic pregnancy rate(3 years)
- Miscarriage rate(3 years)
- Implantation rate(3 years)
- Offspring health (Peripheral blood telomere length)(3 years)