Laparoscopic Tubal Disconnection Versus Laparoscopic Salpingectomy in Infertile Patients

August 23, 2023 updated by: Ahmed Mohammed Elmaraghy, Ain Shams Maternity Hospital

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Infertile ( primary or secondary ).
  2. Age > 30 years .
  3. HSG with unilateral or bilateral hydrosaalpinx , confirmed laparoscopically.
  4. Scheduled for IVF/ICSI

Exclusion Criteria:

  1. Contraindications for laparoscopy

    • Cardiac disease.
    • BMI > 40 kg/m²
    • Previous midline incision .
    • Past history of TB peritonitis .
  2. Proximal tubal block by HCG .
  3. Frozen pelvis proved by previous laparoscopy or laparotomy .
  4. Allergy to contrast media of HSG .
  5. Premature ovarian failure (Serum FSH >40 mIU/ml )
  6. Prescence of Male factor contributing to the infertility proved by abnormal semen analysis
  7. Prescence of Ovarian factor contributing to the infertility proved by the prescence of features suggesting anovulation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tubal disconnection
  1. 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
  2. The electrosurgical generator should set to deliver a power of 25W in nonmodulated mode to desiccate tissue sufficiently
  3. 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
  4. Then, the tube is severed in the middle of the burn area with laparoscopic scissors
  5. Ensure adequate hemostasis
Procedure: Laparoscopic tubal disconnection
  1. 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
  2. The electrosurgical generator should set to deliver a power of 25W in nonmodulated mode to desiccate tissue sufficiently
  3. 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
  4. Then, the tube is severed in the middle of the burn area with laparoscopic scissors
  5. Ensure adequate hemostasis
Active Comparator: Salpingectomy
  1. The tube will be removed from its anatomical attachements by progressive bipolar coagulation
  2. 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
  3. Removal of the tube through one of the ancillary ports using artery forceps
  4. Ensure adequate hemostasis
Procedure: Laparoscopic salpingectomy
  1. The tube will be removed from its anatomical attachements by progressive bipolar coagulation
  2. 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
  3. Removal of the tube through one of the ancillary ports using artery forceps
  4. Ensure adequate hemostasis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ongoing pregnancy rate
Time Frame: From 10 + 0 weeks of gestation
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
Time Frame: 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
in minutes starting from laparoscopic entry into the peritoneal cavity till removal of the primary trocar from the cavity
Intraoperative complications
Time Frame: During the procedure
Bowel injury - Vascular injury
During the procedure
Postoperative complications
Time Frame: First 48 hours after the procedure
ileus - surgical emphysema
First 48 hours after the procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams Maternity Hospital

Investigators

  • Study Director: Hamdy B Alqenawy, M.D.,, Ain Shams university - Faculty of Medicine
  • Principal Investigator: Ahmed G Abd Elrahim, M.D.,, Ain Shams university - Faculty of Medicine
  • Principal Investigator: Alaa S Elsewafy, M.D.,, Ain Shams university - Faculty of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 30, 2023

Primary Completion (Estimated)

August 30, 2024

Study Completion (Estimated)

August 30, 2024

Study Registration Dates

First Submitted

August 23, 2023

First Submitted That Met QC Criteria

August 23, 2023

First Posted (Actual)

August 29, 2023

Study Record Updates

Last Update Posted (Actual)

August 29, 2023

Last Update Submitted That Met QC Criteria

August 23, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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