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临床试验/NCT03620929
NCT03620929Unknown4 期

The Effect of Estrogen in the Prevention of Adhesion Reformation After Hysteroscopic Adhesiolysis

Fu Xing Hospital, Capital Medical University1 个研究点 分布在 1 个国家目标入组 186 人开始时间: 2018年8月13日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
发起方
入组人数
186
试验地点
1
主要终点
AFS score

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 estrogen therapy in the prevention of recurrence of IU adhesions is still controversial. To investigate if estrogen 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 estrogen after hysteroscopic adhesiolysis three months, all patients in this group will be treated with hormone therapy for 3 cycles; each cycle consists of estradiol 4mg per day for 21 days with addition of progestogen in the form of dydrogesterone 10mg per day for the last 7 days; and the control group without estrogen 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

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 estrogen. However, it is still not known if estrogen therapy is indeed necessary or effective. In a prospective randomized study which evaluated the efficacy of estrogen in preventing IUA following hysteroscopic septal resection, it was found that estrogen 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 adjuvant hormonal medication. On the other hand, large doses of estrogen may result in endometrium fibrosis and inhibited endometrium receptivity.

It seems that the role of postoperative estrogen therapy in the prevention of recurrence of IU adhesions is still controversial. In this prospective, randomized, controlled study, we wish to determine if estrogen 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 estrogen therapy can prevent adhesion reformation after adhesiolysis.

Patients The patients will be recruited from the hysteroscopy Center of the Fuxing Hospital, Beijing, China. Before the surgery all patients with suspected Asherman syndrome will undergo preoperative evaluations, including a detailed history of the menstrual pattern, any previous intrauterine surgery, reproductive history, as well as trans-vaginal ultrasonography. The severity and extent of intrauterine adhesions will be scored according to a classification system recommended by the American Fertility Society (AFS) (1988 version). The inclusion criteria include [1] women aged 18-40 years; written consent obtained; and agreement to have second-look hysteroscopy. The exclusion criteria included:1 has received estrogen therapy within 3 month of enrolment. 2 suffers from leiomyoma, endometrial polyps, cancer, or polycystic ovarian syndrome (PCOS). 3.History of genital tuberculosis; and 4. contraindications for estrogen therapy.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

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

入选标准

  • patients with suspected Asherman syndrome

排除标准

  • 1 has received estrogen therapy within 3 month of enrolment. 2 suffers from leiomyoma, endometrial polyps, cancer, or polycystic ovarian syndrome (PCOS). 3.History of genital tuberculosis; and
  • contraindications for estrogen therapy.

研究组 & 干预措施

Experiment group

Experimental

Having estrogen(Estradiol Valerate) after hysteroscopic adhesiolysis three months, all patients in this group will be treated with hormone therapy for 3 cycles; each cycle consists of estradiol 4mg per day for 21 days with addition of progestogen in the form of dydrogesterone 10mg per day for the last 7 days;

干预措施: Estradiol Valerate (Drug)

结局指标

主要结局

AFS score

时间窗: 3 months

The severity and extent of intrauterine adhesions will be scored according to a classification system recommended by the American Fertility Society (AFS) (1988 version).

次要结局

未报告次要终点

研究者

发起方
Fu Xing Hospital, Capital Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yang Ling Ling

principal investigator

Fu Xing Hospital, Capital Medical University

研究点 (1)

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