The Effect of Platelet Rich Plasma in the Prevention of Adhesion Reformation After Hysteroscopic Adhesiolysis
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- AFS Score at Third-look Hysteroscopy
研究概览
简要总结
Asherman syndrome, which occurs after trauma to the basalis layer of the endometrium. It seems that the role of postoperative platelet rich plasma（PRP）therapy in the prevention of recurrence of IUA is still controversial. To investigate if PRP therapy can prevent adhesion reformation after adhesiolysis.
After the completion of hysteroscopic adhesiolysis, recruited patients will be randomized to one of the two treatment groups by computer-generated numbers: having PRP after hysteroscopic adhesiolysis; and the control group without PRP treatment. A second-look hysteroscopy and ultrasound assessment of the endometrium will be carried out 4 weeks after the surgery, and again at 8 weeks after the surgery.
详细描述
Asherman syndrome, which occurs after trauma to the basalis layer of the endometrium. It seems that the role of postoperative platelet rich plasma（PRP）therapy in the prevention of recurrence of IUA is still controversial. To investigate if PRP therapy can prevent adhesion reformation after adhesiolysis.
After the completion of hysteroscopic adhesiolysis, recruited patients will be randomized to one of the two treatment groups by computer-generated numbers: having PRP after hysteroscopic adhesiolysis; and the control group without PRP treatment. A second-look hysteroscopy and ultrasound assessment of the endometrium will be carried out 4 weeks after the surgery, and again at 8 weeks after the surgery.
Background information Asherman syndrome, which occurs after trauma to the basalis layer of the endometrium generally after endometrial curettage, may manifest as hypomenorrhea, amenorrhea, dysmenorrhea, infertility or recurrent miscarriage.
At present, hysteroscopic adhesiolysis is the recommended standard diagnostic method and treatment for IUA. Recurrence of uterine cavity adhesion post-operatively is frequently reported, especially in severe IUA patients. A number of strategies have been proposed to prevent recurrence of adhesion reformation, including the use of post-operative PRP. However, it is still not known if PRP therapy is indeed necessary or effective. In a prospective randomized study which evaluated the efficacy of PRP in preventing IUA following hysteroscopic adhesiolysis , it was found that PRP did not have any benefit in reducing adhesion formation. In another RCT study on women with Asherman syndrome, there did not appear to be any difference in the recurrence of IUA and pregnancy rate between those who did or did not receive PRP medication. It seems that the role of postoperative PRP therapy in the prevention of recurrence of IUA is still controversial. In this prospective, randomized, controlled study, we wish to determine if PRP therapy is of benefit in preventing adhesion reformation after IUA for Asherman syndrome. As the effect may be different for subjects with different degrees of IUA, we propose to stratify the subjects into those with mild and severe IUAs.
Objectives To investigate if PRP therapy can prevent adhesion reformation after adhesiolysis.
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 (Investigator)
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
- •Written consent obtained; agreement to have second-look hysteroscopy.
排除标准
- •has received estrogen therapy within 3 month of enrolment.
- •suffers from leiomyoma, endometrial polyps, cancer, or polycystic ovarian syndrome (PCOS). 3.History of genital tuberculosis.
研究组 & 干预措施
PRP Group
After the completion of hysteroscopic adhesiolysis, recruited participants will be randomized to one of the two treatment groups by computer-generated numbers: Immediately administer uterine perfusion with PRP after surgery, and administered PRP perfusion during hysteroscopy at 4 and 8 weeks after hysteroscopic adhesiolysis, A second-look hysteroscopy and ultrasound assessment of the endometrium will be carried out 4 weeks after the surgery, and again at 8 weeks after the surgery.
干预措施: PRP group (Biological)
结局指标
主要结局
AFS Score at Third-look Hysteroscopy
时间窗: 8 weeks after operation
The investigators measured the AFS score between the PRP group and Control group through hysteroscopy 8 weeks after operation. American Fertility Society \[(AFS) score in intrauterine adhesion who underwent hysteroscopic adhesiolysis.The higher the score, the heavier the degree of adhesion. The AFS (American Fertility Society) scoring system for endometrial assessment is as follows: Extent of involvement: 1 point(\<1/3 of the uterine cavity); 2 points(1/3 to 2/3 of the uterine cavity); 4 points(2/3 of the uterine cavity). Type of adhesion:1 point(Filmy); 2 points(Filmy and dense); 4 points(Dense) . Menstrual pattern:1 point(Normal menses); 2 points(Menstrual reduction); 4 points(Amenorrhea) . Points are summed to give a total score ranging from 1 to 12, which is used to classify the degree of endometrial injury or disease:Mild (Grade I): 1 to 4 points;Moderate (Grade II): 5 to 8 points;Severe (Grade III): 9 to 12 points.
Endometrial thickness under ovulation ultrasound
时间窗: 3 months
Ultrasound measurement of endometrial thickness during ovulation period three months after adhesion release surgery
次要结局
未报告次要终点
研究者
Yang Ling Ling
Dr
Fu Xing Hospital, Capital Medical University