Clinical Study of in Situ Regeneration of Endometrium
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 345
- 试验地点
- 1
- 主要终点
- Endometrial thickness
研究概览
简要总结
Thin endometrium will lead to hypomenorrhea，infertility and recurrent pregnancy loss and there are few effective methods to increase the endometrial thickness and improve the fertility outcomes. Patients with thin endometrium will be divided into three groups and receive estrogen therapy, stem cell therapy and growth factor therapy respectively. This randomized controlled clinical study is carried out to explore the optimal treatment method and best indications for thin endometrium.
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 42 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •1.Patients with thin endometrium (4mm≤ EMT <7mm )or scarred endometrium (scarred area≤70%) which is nonresponsive to estrogen stimulation 2.Infertile patients with clear fertility desires 3.20-42 years old 4.Normal ovarian function or with frozen embryos 5.Willing to participate in follow-up
排除标准
- •Endometrial thickness <4mm or scarred endometrial area>70%
- •Uterine cavity out of shape and the cavity depth<6.5mm
- •Abnormal chromosome karyotype
- •Uterine diseases including large intramural myomas, severe endometriosis, severe adenomyosis, severe congenital uterine malformations, endometrial tuberculosis, vaginitis and endometritis
- •Systemic diseases: hypertension, diabetes, and so on
- •Contraindications to pregnancy
- •Contraindications to hormone replacement therapy
- •Medical history of pelvic tumors or receiving pelvic radiotherapy 9 .Involved in other clinical studies
- •Unable to adhere to the follow-up
研究组 & 干预措施
CBD-bFGF
干预措施: CBD-bFGF (Drug)
Collagen/BMMNCs
干预措施: Collagen/BMMNCs (Drug)
Estrogen
干预措施: Estrogen (Drug)
结局指标
主要结局
Endometrial thickness
时间窗: 6 months
Endometrial thickness evaluated by transvaginal sonography during late proliferative phase
Ongoing pregnancy rate
时间窗: 24 months
The presence of a living intrauterine fetus on TVU at the 12th week of gestation
次要结局
- Pregnancy related complications(24 months)
- Endometrial blood flow(6 months)
- Histological changes of endometrium(12 months)
- Menstrual blood volume(6 months)
研究者
Yali Hu
Professor，Chief Physician of Obstetrics and Gynecology
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School