Effects of Dienogest and Dienogest Plus Estradiol Valerate on Ovarian Reserve and Endometrioma Size
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 710
- 试验地点
- 1
- 主要终点
- Ovarian reserve
研究概览
简要总结
Progesterone resistance in endometriosis is a known fact. The progestin derivatives used in endometriosis cause decidualization and atrophy of ectopic foci. Moreover, they inhibit neo-angiogenesis, provide suppress expansile/destructive growth facilitated by matrix metalloproteinases, and implantation of ectopic foci. The effect of drugs containing the estrogen-progesterone combination is mainly based on the inhibition of ovulation, decidualization and atrophy of ectopic foci. In estrogen-progesterone mechanism, it is known that estrogen has a progesterone receptor-enhancing effect, which may make progesterone more potent. Based on this, the investigators hypothesized that estrogen added to progesterone could lead to a further reduction in endometrioma size by various mechanisms which probably include the increased progesterone sensitivity in endometriosis. In addition, the investigators hypothesized that this therapy can alleviate the destructive effect of endometriomas on the ovarian reserve.
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 (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
- 是
入选标准
- •Study Group: At least one endometrioma greater than 3 cm, between 18-40 years of age, without surgical indication at the time of diagnosis, occasionally and intermittently controlled pain with NSAIDs or no pain symptom
- •Control Group: Patients with reproductive age without any ovarian cysts
排除标准
- •suspicion of malignancy, irregular mentrual period, endocrine diseases, drug intake that may affect ovarian reserve in the last 6 months (i.e GnRH agonists), previous ovarian surgery, AMH levels under 2 ng/ml.
研究组 & 干预措施
Study Group (patients with OMA)
I) Untreated patients (n=142)
II) Dienogest (n=142)
III) Dienogest/Estradiol valerate+Dienogest (n=142)
干预措施: Estradiol valerate/dienogest (Drug)
Control Group(patients without OMA)
I) Untreated patients (n=142)
II) Dienogest/Estradiol valerate+Dienogest (n=142)
干预措施: Estradiol valerate/dienogest (Drug)
结局指标
主要结局
Ovarian reserve
时间窗: up to 24 months
The investigators evaluate serum anti-Müllerian hormone (AMH) level(ng/mL) using commercial elisa kits and antral follicle count (number) using ultrasonography. The patients with higher ovarian reserve represent a better outcome.
次要结局
- Pain Score(up to 24 months)
- Endometrioma Size(up to 24 months)