Lipoic Acid Supplementation in IVF
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 172
- 试验地点
- 1
- 主要终点
- Number of implants per cycle
研究概览
简要总结
Alpha-Lipoic Acid (ALA) is a natural molecule that can make a significant contribution to the success of embryo implantation phase, because it exerts, directly or indirectly, an immunomodulatory activity. ALA has the ability to regenerate antioxidants molecules that facilitate embryo implantation, and to stimulate the production of local mediators useful for implantation. This study is a prospective clinical trial and aims to evaluate the reproductive outcomes of Italian couples following oocyte donation fresh cycles when receiving per os tablets of lipoic acid. Indeed, the control group had only the standard treatment (vaginal progesterone), whereas the study group, in addition to that, received ALA (300 mg, 2 times per day) by oral route, from the day of donors oocyte pick up until the pregnancy test. If the childbearing occurred, treatment continued until the 8th week of pregnancy. Primary outcome of the study is the implantation rate while the positive hCG rate, the clinical pregnancy rate, the miscarriage rate and the live-birth rate are secondary outcomes .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
入排标准
- 年龄范围
- 30 Years 至 50 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Proof of fertility;
- •⩽32 years old
- •BMI <30 kg/m2
- •Regular menstrual cycles of 25-33 days
- •Two normal ovaries based on transvaginal scan findings.
- •Recipients:
- •Women with infertility problems
- •⩽50 years old,
- •BMI <34 kg/m2
排除标准
- •Polycystic ovaries
- •Endometriosis
- •Gynaecological or medical disorders.
- •Recipients:
- •Endocrinologic problems
- •Medication for chronic illness
- •Azoospermic partner that require TESE
- •Sperm donation cycles
研究组 & 干预措施
ALA + P
Oral alpha-lipoic acid + vaginal Progesterone
干预措施: Oral Lipoic acid (Dietary Supplement)
ALA + P
Oral alpha-lipoic acid + vaginal Progesterone
干预措施: Vaginal Progesterone (Drug)
P
vaginal Progesterone
干预措施: Vaginal Progesterone (Drug)
结局指标
主要结局
Number of implants per cycle
时间窗: Within 7 weeks after blastocystis transfer
Implantation rate is defined as the percentage of transferred embryos that develop at least to the stage of fetal heart activity documented by pregnancy ultrasound.
次要结局
- Number of biochemical pregnancies per group(Within 7 weeks after blastocystis transfer)
- Number of miscarriage per group(Within 22 weeks of gestation)
- Number of live birth per group(At delivery)
- Number of clinical pregnancies per group(7 weeks of gestation)
