跳至主要内容
临床试验/NCT03023514
NCT03023514已完成4 期

Lipoic Acid Supplementation in IVF

Lo.Li.Pharma s.r.l1 个研究点 分布在 1 个国家目标入组 172 人开始时间: 2015年3月最近更新:
适应症
干预措施
相关药物

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

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

Experimental

Oral alpha-lipoic acid + vaginal Progesterone

干预措施: Oral Lipoic acid (Dietary Supplement)

ALA + P

Experimental

Oral alpha-lipoic acid + vaginal Progesterone

干预措施: Vaginal Progesterone (Drug)

P

Active Comparator

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)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验