Laparoscopic Tubal Disconnection Versus Laparoscopic Salpingectomy in Infertile Patients Scheduled for IVF/ICSI. Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 150
- 主要终点
- Ongoing pregnancy rate
研究概览
简要总结
Tubal factor infertility is known to be one of the most common indications for IVF treatment. Patients with hydrosalpinges have been identified to have poor pregnancy outcomes such as lower implantation and pregnancy rates & higher rates of spontaneous abortion and ectopic pregnancies. Surgical intervention can be recommended for patients with hydrosalpinx prior to IVF/ICSI.
This study will be done at Ain Shams University Maternity Hospital, to compare laparoscopic salpingectomy & laparoscopic tubal disconnection as two surgical modalities of treatment of unilateral or bilateral hydrosalpinges in women older than 30 years and scheduled for IVF/ICSI, regarding implantation rates, clinical pregnancy rates, ongoing pregnancy rates, ectopic pregnancy rates, and operative complications.
详细描述
It is estimated that tubal factors account for 14% of the causes of subfertility in women. The prevalence of hydrosalpinx among tubal diseases is as high as 30% of couples presenting with infertility from tubal factors.
Hydrosalpinx is the dilation of the fallopian tube in the presence of distal tubal occlusion, which may result from several causes. The leading cause of distal tubal occlusion is pelvic inflammatory disease (PID), usually resulting from a prior sexually transmitted disease, such as Chlamydia trachomatis or Neisseria gonorrhoeae. Tubal tuberculosis is an uncommon cause of hydrosalpinx, though re-emerging in developed countries. Other etiologies include endometriosis, appendicitis, and abdominopelvic surgery.
Depending on several patient factors, tubal microsurgery, or more commonly IVF with its improving success rates, are the recommended treatment options for tubal factor infertility.
In addition to its essential role in infertility, hydrosalpinx has an adverse effect on the outcome of in vitro fertilization (IVF) Hydrosalpinx can decrease the clinical pregnancy rate of IVF-ET, and increase the incidence of abortion and ectopic pregnancy.
The presence of hydrosalpinx has a negative effect on IVF/ET because of the suspected embryotoxicity of the hydrosalpingeal fluid due to a combination of mechanical and chemical factors thought to disrupt the endometrial environment.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 30 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Infertile ( primary or secondary ).
- •Age > 30 years .
- •HSG with unilateral or bilateral hydrosaalpinx , confirmed laparoscopically.
- •Scheduled for IVF/ICSI
排除标准
- •Contraindications for laparoscopy
- •Cardiac disease.
- •BMI > 40 kg/m²
- •Previous midline incision .
- •Past history of TB peritonitis .
- •Proximal tubal block by HCG .
- •Frozen pelvis proved by previous laparoscopy or laparotomy .
- •Allergy to contrast media of HSG .
- •Premature ovarian failure (Serum FSH >40 mIU/ml )
- •Prescence of Male factor contributing to the infertility proved by abnormal semen analysis
- •Prescence of Ovarian factor contributing to the infertility proved by the prescence of features suggesting anovulation
结局指标
主要结局
Ongoing pregnancy rate
时间窗: From 10 + 0 weeks of gestation
Pregnancy with detectable heart beat 10weeks gestation or beyond
次要结局
- Intraoperative complications(During the procedure)
- Operative time(in minutes starting from laparoscopic entry into the peritoneal cavity till removal of the primary trocar from the cavity)
- Postoperative complications(First 48 hours after the procedure)
研究者
Ahmed Mohammed Elmaraghy
Lecturer in Obstetrics and Gynecology
Ain Shams Maternity Hospital