A Prospective, Randomized, Controlled Trial Comparing 2 Different Doses of Estrogen Therapy After Hysteroscopic Adhesiolysis as an Adjuvant to Prevent Recurrence of Intrauterine Adhesions
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 141
- 试验地点
- 1
- 主要终点
- the AFS Score at Second-look Hysteroscopy
研究概览
简要总结
This single-center,prospective,randomized,controlled trial is conducted to evaluate the efficacy of different doses of estrogen artificial periodic therapy after hysteroscopic adhesiolysis in patients with moderate-severe adhesion.
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 (Investigator)
入排标准
- 年龄范围
- 25 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Moderate and severe IUA according to the AFS IU adhesion scoring system (AFS 1988 version) (19) showed in Table1 (AFS score≥5);
- •Scheduled for hysteroscopic adhesiolysis;
- •Agreed to have two follow-up hysteroscopy; and
- •Written, informed consent obtained.
排除标准
- •Received estrogen therapy within 3 months of enrollment;
- •Suffering from leiomyoma, polyps, cancer, or polycystic ovarian syndrome (PCOS);
- •History of genital tuberculosis; and
- •Contraindication for estrogen therapy.
研究组 & 干预措施
Low dose of oestrogen
Patients in this group will build artificial cycle by Femoston.(oral one red tablet daily for 11 days and oral one yellow tablet in the next 10 days). This process will last for 3 months after the surgery.
P.S.1.A red tablet contains 2mg estradiol. 2.A yellow tablet contains 2mg estradiol and 10mg dydrogesterone.
干预措施: Femoston (Drug)
High dose of oestrogen
Patients in this group will build artificial cycle by Femoston.(oral three red tablets daily for 11 days and oral two yellow tablets in the next 10 days). This process will last for 3 months after the surgery.
P.S.1.A red tablet contains 2mg estradiol. 2.A yellow tablet contains 2mg estradiol and 10mg dydrogesterone.
干预措施: Femoston (Drug)
结局指标
主要结局
the AFS Score at Second-look Hysteroscopy
时间窗: 1 months after the surgery
The AFS score is based on the American Fertility Society (AFS) Classification of Intra-uterine adhesions( 1988 version)The total range of AFS score is from 0 to 12, and the higher the score is, the worse the outcome is.
次要结局
- the AFS Score at Third-look Hysteroscopy(2 months after surgery)
- Participants With Improvement of Menstrual Pattern at Third-look Hysteroscopy(3 months after surgery)
研究者
Jun Guo
Chief Physician
Fu Xing Hospital, Capital Medical University