Phase I Study of the Effect of Flushing the Uterine Cavity With Follicular Fluid After Ovum Pick-up on Implantation Rates in ICSI Cycles
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- pregnancy rate
研究概览
简要总结
Background:
Traditionally during ovum pick-up in ICSI, we aspirate the follicles for oocyte retrieval but unfortunately we don't make use of the follicular fluid (FF) and we discard it in spite of the fact that this does not happen in nature. The fallopian tube picks-up the FF with the oocyte during ovulation. As this fluid contains stem cell factor and C-Kit receptor responsible for implantation and IGF responsible for endometrial growth and TGF that improves implantation. That's why flushing the endometrial cavity with FF after ovum pick-up might improve endometrial receptivity and implantation rates; the limiting step in ICSI.
Patients and Methods:
100 patients attending kasr El-Aini IVF center preparing for ICSI cycles are randomized into two groups. In the study group, flushing the endometrial cavity with 2ml of clear follicular fluid surrounding mature oocytes through an IUI catheter is done after ovum pick-up While in the control group, no flushing of the endometrial cavity with FF is done. The implantation rates and pregnancy rates in both groups will be assessed.
详细描述
Introduction:
Looking at the process of IVF, we found that we only make use of the ovum and sperm and we neglect completely the valuable effect of the follicular fluid which is currently attracting a lot of attention. Several studies revealed a pivotal role played by this fluid in the process of fertilization and implantation as it is rich in growth factors as stem cell factor, transforming growth factor and insulin growth factor and cytokines (1,2).
Macciò study confirmed that follicular fluid (FF) contains factors that induce immunosuppression and explained that the immunosuppressive activity of FF is mediated by the specific inhibition of the production of IL-1 alpha and IL-2 and by the decreased expression of the CD25 (3).
During ovum pick-up, we aspirate all the FF and throw it away after ovum retrieval. This fluid normally enters the fallopian tubes while picking the ovum during ovulation in natural cycles and it reaches the uterine cavity as well and several studies suggested that it might have a crucial role in modifying uterine receptivity preparing the endometrium for the fertilized ovum arriving after 3 days as the TGF controls apoptosis, the IGF improves endometrial thickness and the immunosuppressive activity of the FF paves the way for the embryo to implant in the uterine cavity (4,5).
Actually Hunter study in 2007, provided circumstantial evidence for entry of follicular fluid into the Fallopian tubes, especially close to the time of ovulation, with the suggestion that such entry could modify the nature of endosalpingeal secretion and transudation. Thereafter, the spectrum of gonadal hormones in follicular fluid could be influencing uterine tissues in a local manner (5).
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
- None
入排标准
- 年龄范围
- 20 Years 至 38 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Maternal age ranges from 20-38 years.
- •Basal FSH < 10 mIU/ml.
- •BMI < 35 kg/m
- •Estradiol level > 1000 at the day of HCG administration.
- •Estradiol level < 4000 at the day of HCG administration.
排除标准
- •Presence of Endometriosis.
- •Presence of Hydrosalpinx.
- •Presence of vaginal infection.
- •Presence of galactorrhea.
- •Presence of hormonal disorders.
- •Severe male factor infertility:
- •Sperm Count < one million. Marked malformation
- •history of recurrent abortion.
结局指标
主要结局
pregnancy rate
时间窗: 17 days
The main outcome is the pregnancy rate in ICSI cycles after flushing the uterine cavity with follicular fluid after ovum pick-up in the study group and comparing it with the control group.
次要结局
- Implantation rate(17 days)
研究者
Nawara Mohamed Hashish
Assistant professor of Obstetrics and Gynecology
Kasr El Aini Hospital