NCT01224080Unknown2 期
Use of Adiana Tubal Occlusive Devices in Women With Hydrosalpinx Prior to In Vitro Fertilization
Reproductive Science Center2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2010年10月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Evaluate the success rate of proximal tubal occlusion with Adiana inserts in women with hydrosalpinx
研究概览
简要总结
A condition called hydrosalpinx occurs when one or both of the fallopian tubes is blocked with fluid. The fluid can leak into the tube and the uterus. The theory is that the fluid can harm the tubes and uterus making implantation more difficult or harm the embryo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 43 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Are willing to participate in this clinical study
- •Are able to comprehend and give informed consent for participation in this study
- •Have read, understood and signed an informed consent form
- •Have been unable to achieve pregnancy after trying for 1 year or greater and who have unilateral or bilateral hydrosalpinges as evidenced by laparoscopy or ultrasound or HSG
- •Have a Day #3 serum FSH<10, and Day #3 Estradiol<80
- •Recipient women undergoing a ovum donor cycle the donor must have a Day 3 serum FSH < 10 and Day 3 Estradiol < 80
- •Have an antral follicle count 10 or greater for both ovaries combined, if women using ovum donor (follicle count) will be based on eligible donor
- •Have a desire to receive treatment for their HS
- •Are willing to undergo a hysterosalpingogram (HSG) 3 months after ADIANA placement to confirm proximal tubal occlusion
排除标准
- •Active or recent upper or lower pelvic infection
- •Known hypersensitivity to nickel as confirmed by skin test
- •Known allergy to contrast media
- •Pregnancy or suspected pregnancy
- •Delivery or termination of pregnancy less than six weeks prior to Adiana placements
- •BMI > 35
- •Abnormal pap smear (CIN2 or greater abnormality) within the past year
- •Pelvic malignancy
- •Severely retroverted uterus
- •Evidence of intrauterine abnormalities such as submucous fibroids, polyps, intrauterine adhesions or presence of a uterine septum
- •Abnormal Clomid Challenge Test or abnormal lab values on Day #3 serum FSH and Estradiol
- •Antral follicle count less than 10 (both ovaries combined)
- •Poor general or gynecologic health
- •Inability or refusal to provide informed consent
结局指标
主要结局
Evaluate the success rate of proximal tubal occlusion with Adiana inserts in women with hydrosalpinx
时间窗: 1 Year
Analysis of results will be performed on the intent-to-treat population defined as all subjects in whom device placement was attempted and on the per protocol population defined as all subjects who had successful placement of the Adiana occlusion device and were followed for a minimum of one year post HSG confirmation test.
次要结局
- Observe implantation and clinical pregnancy rates post IVF(1Year)
研究者
研究点 (2)
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