Laparoscopic Tubal Disconnection Versus Laparoscopic Salpingectomy in Infertile Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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. Surgical treatment should be considered for all women with hydrosalpinges prior to IVF treatment (Johnson et al .,2004 ) Removing (salpingectomy) or occluding blocked or diseased fallopian tubes before IVF can increase pregnancy and live birth rates for women on the IVF program. A network meta-analysis showed that Proximal tubal occlusion, salpingectomy, and aspiration for treatment of hydrosalpinx scored consistently better than did no intervention for the outcome of IVF/ET. Tubal occlusion and salpingectomy also improve ongoing pregnancy rates. Proximal tubal occlusion ranks highest for most of the outcomes assessed, whereas no intervention scores consistently as the least effective strategy for all outcomes

Official Title
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Laparoscopic Tubal Disconnection Versus Laparoscopic Salpingectomy in Infertile Patients Scheduled for IVF/ICSI. Randomized Controlled Trial

Conditions
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Infertility, Female

Intervention / Treatment
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* Procedure: Laparoscopic tubal disconnection
* Procedure: Laparoscopic salpingectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Infertile ( primary or secondary ). Age > 30 years . HSG with unilateral or bilateral hydrosaalpinx , confirmed laparoscopically. Scheduled for IVF/ICSI Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tubal disconnection<br>The tube is grasped in the isthmic portion of the tube at least 2cm from the cornua. Bipolar coagulation will provide a more localized area of tubal burn so requiring at least 3cm of the tube to be coagulated The electrosurgical generator should set to deliver a power of 25W in nonmodulated mode to desiccate tissue sufficiently The tube should be coagulated with 2 to 3 contiguous burns to provide an area of about 3cm of coagulation. Th endpoint of coagulation is cessation of the current flow Then, the tube is severed in the middle of the burn area with laparoscopic scissors Ensure adequate hemostasis | Procedure: Laparoscopic tubal disconnection<br>* The tube is grasped in the isthmic portion of the tube at least 2cm from the cornua. Bipolar coagulation will provide a more localized area of tubal burn so requiring at least 3cm of the tube to be coagulated The electrosurgical generator should set to deliver a power of 25W in nonmodulated mode to desiccate tissue sufficiently The tube should be coagulated with 2 to 3 contiguous burns to provide an area of about 3cm of coagulation. Th endpoint of coagulation is cessation of the current flow Then, the tube is severed in the middle of the burn area with laparoscopic scissors Ensure adequate hemostasis<br>|
| Active Comparator: Salpingectomy<br>The tube will be removed from its anatomical attachements by progressive bipolar coagulation Progressive coagulation and cutting of the mesosalpinx begins at the proximal isthmus of the tube and progresses to the fimbriated end using bipolar coagulation and laparoscopic scissors Removal of the tube through one of the ancillary ports using artery forceps Ensure adequate hemostasis | Procedure: Laparoscopic salpingectomy<br>* The tube will be removed from its anatomical attachements by progressive bipolar coagulation Progressive coagulation and cutting of the mesosalpinx begins at the proximal isthmus of the tube and progresses to the fimbriated end using bipolar coagulation and laparoscopic scissors Removal of the tube through one of the ancillary ports using artery forceps Ensure adequate hemostasis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ongoing pregnancy rate | Pregnancy with detectable heart beat 10weeks gestation or beyond | From 10 + 0 weeks of gestation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operative time | in minutes starting from laparoscopic entry into the peritoneal cavity till removal of the primary trocar from the cavity | in minutes starting from laparoscopic entry into the peritoneal cavity till removal of the primary trocar from the cavity | 
| Intraoperative complications | Bowel injury - Vascular injury | During the procedure | 
| Postoperative complications | ileus - surgical emphysema | First 48 hours after the procedure |