Trans-vaginal Aspiration With or Without Injection of Surgicel for Treatment of Small Ovarian Endometrioma Before ICSI Cycles. A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- clinical pregnancy rate
研究概览
简要总结
women candidate for ICSI and having ovarian endometrioma smaller than 5 cm will be randomized to either transvaginal aspiration alone or transvaginal aspiration follwed by injection of small parts of oxidized regenerated cellulose within the cyst cavity during the cycle that preceded the induction cycle of ICSI
详细描述
women candidate for ICSI and having ovarian endometrioma smaller than 5 cm will be randomized to either transvaginal aspiration alone or transvaginal aspiration follwed by injection of small parts of oxidized regenerated cellulose within the cyst cavity during the cycle that preceded the induction cycle of ICSI.
Transvaginal aspiration will be done under ultrasonographic guidance with spinal needle insertion inside the cyst cavity followed by aspiration of the chocolate material from the cyst & then irrigation of the cyst cavity with normal saline solution till complete elimination of the chocolate material. The needle will be withdrawn in women in non-Surgicel group while injection of small pieces of surgicel inside the cyst cavity will be done for women in the surgicel group followed by withdrawal of the needle.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Subfertile women indicated for ICSI
- •having a single endometrioma of less than 5 cm with typical sonographic criteria; a cyst with 1 to 4 locules and ground glass appearance of the cyst fluid with no papillary projections and no or minimal vascularization of the cyst capsule. Since endometriotic cysts measuringmore than 1 cm are readily diagnosed by ultrasound,25 we chose a diameter of 2 cm as the lower limit to declare a cyst as endometrioma.
- •All cases had a normal uterine cavity demonstrated by ultrasonography and hysteroscopy.
排除标准
- •bilateral or multiple endometriomas, lesions of more than 5 cm or showing atypical sonographic features presence of uterine pathology (eg, polyp or fibroid)
- •follicle-stimulating hormone (FSH) of more than 10,
- •body mass index of more than 30, age more than 40 years,
- •cases who received previous GnRH therapy for treatment of endometriosis within 12 months of the study
- •patients who received oral contraceptive pills or any form of hormones for the previous 3 months,
- •patients with previous surgical resection of endometrioma
- •severe male factor.
研究组 & 干预措施
Non surgicel group
under sedation transvaginal insertion of spinal needle through the cul de sac under ultrasonographic guidance to reach cyst cavity followed by aspiration of the chocolate material followed by irrigation of the cyst cavity with normal saline solution till complete elimination of the chocolate material
干预措施: Transvaginal aspiration (Procedure)
Non surgicel group
under sedation transvaginal insertion of spinal needle through the cul de sac under ultrasonographic guidance to reach cyst cavity followed by aspiration of the chocolate material followed by irrigation of the cyst cavity with normal saline solution till complete elimination of the chocolate material
干预措施: Intracytoplasmic sperm injection (Drug)
Surgicel group
under sedation transvaginal insertion of spinal needle through the cul de sac under ultrasonographic guidance to reach cyst cavity followed by aspiration of the chocolate material followed by irrigation of the cyst cavity with normal saline solution till complete elimination of the chocolate material follwed by insertion of 3-4 pieces of small surgicel inside the cyst cavity
干预措施: transvaginal aspiration and surgicel injection (Procedure)
Surgicel group
under sedation transvaginal insertion of spinal needle through the cul de sac under ultrasonographic guidance to reach cyst cavity followed by aspiration of the chocolate material followed by irrigation of the cyst cavity with normal saline solution till complete elimination of the chocolate material follwed by insertion of 3-4 pieces of small surgicel inside the cyst cavity
干预措施: Intracytoplasmic sperm injection (Drug)
结局指标
主要结局
clinical pregnancy rate
时间窗: 14 days after embryo transfer
documentation of intrauterine fetal sac using transvaginal ultrasound
次要结局
未报告次要终点
研究者
Ahmed Maged
Principal investigator
Cairo University