跳至主要内容
临床试验/NCT03862586
NCT03862586已完成3 期

Effect of N-Acetyl Cysteine on Expression of HOXA Cluster Genes in Endometrium of Women With Recurrent Implantation Failure (RIF) During Implantation Window: a Double-blinded Randomized Research

Royan Institute0 个研究点目标入组 40 人开始时间: 2015年2月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
40
主要终点
Expression of HOXA in endometrium

研究概览

简要总结

Comparison of the group treated with NAC-supplementation and placebo- administered groups showed elevations in HOXA cluster genes (all members) expression level in endometrium of women with RIF.

详细描述

Despite significant developments in assistant reproductive technology (ART) that have overcome many underlying causes of infertility, pregnancy success rates remain relatively low, mainly due to implantation failure. Embryo quality and endometrial receptivity are two significant factors that believed to be the key points in implantation. Since recent studies that showed high expression of some HOXA genes affects on successful implantation rate, thus we examined the expression of HOXA genes in NAC supplementation during window of implantation (WOI) in women with (RIF). Also the effect of NAC on the improvement of implantation in RIF patients was investigated. Forty unfertile women with a diagnosis of RIF, referred to Royan Institute were included in the study. The study was of the type a single center, double blinded, placebo controlled, randomized trial. Expression of HOXA genes were assessed on the day of WOI (using Real Time PCR) biopsies from endometrium. Subjects randomly assigned to receive either NAC (A) or placebo (B) with both effervescent tablets having similar color, size and appearance. The patients were randomly categorized in two groups (A/B) to receive NAC 1200 mg/day or placebo, for at-least 6 weeks before starting ovarian stimulation. Pipelled-based biopsy from endometrium was done on specific day (19-21) of their cycle. Then patients were undergone ovarian stimulation (using NAC) ended to IVF treatment. RNA extraction and cDNA synthesis were performed from endometrium samples and then we evaluated expressions levels by Real-time PCR. Then we analyzed our data by independent Sample T-test and Mann-whitney U Test.

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
Double (Participant, Investigator)

入排标准

年龄范围
22 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Age between 20 and 40 years old
  • At least two IVF failure
  • BMI in the normal range

排除标准

  • Irregular menstrual cycle
  • Taking hormonal drugs except thyroid medication
  • Abnormal karyotype or chromosomal disorders
  • Coagulation problems.

研究组 & 干预措施

N-acetyl cysteine

Experimental

Twenty two infertile women with the onset of endometrial preparation for evaluating genes expression, received 1200 mg of oral N-acetyl cysteine for at-least six weeks before starting ovarian stimulation

干预措施: N-acetyl cysteine (Drug)

Placebos

Placebo Comparator

Eighteen infertile women with the onset of endometrial preparation for evaluating genes expression, received placebo effervescent tablet for at-least six weeks before starting ovarian stimulation

干预措施: Placebos (Drug)

结局指标

主要结局

Expression of HOXA in endometrium

时间窗: approximately 20 days after the first day of menstruation (each day is 28 days)

mRNA expression by quantitative PCR for homeo box A

次要结局

  • Positive pregnancy test(16 days after embryo transfer)
  • Endometrium thickness(approximately 20 day after the first day of menstruation (each day is 28 days))

研究者

申办方类型
Other Gov
责任方
Sponsor

相似试验