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Laparoscopic Tubal Disconnection Versus Laparoscopic Salpingectomy in Infertile Patients

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ClinicalTrials.gov Identifier: NCT06015698
Recruitment Status : Not yet recruiting
First Posted : August 29, 2023
Last Update Posted : August 29, 2023
Sponsor:
Information provided by (Responsible Party):
Ahmed Mohammed Elmaraghy, Ain Shams Maternity Hospital

Study Description
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Infertility, Female Procedure: Laparoscopic tubal disconnection Procedure: Laparoscopic salpingectomy Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Laparoscopic Tubal Disconnection Versus Laparoscopic Salpingectomy in Infertile Patients Scheduled for IVF/ICSI. Randomized Controlled Trial
Estimated Study Start Date : August 30, 2023
Estimated Primary Completion Date : August 30, 2024
Estimated Study Completion Date : August 30, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Ongoing pregnancy rate [ Time Frame: From 10 + 0 weeks of gestation ]
    Pregnancy with detectable heart beat 10weeks gestation or beyond


Secondary Outcome Measures :
  1. 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

  2. Intraoperative complications [ Time Frame: During the procedure ]
    Bowel injury - Vascular injury

  3. Postoperative complications [ Time Frame: First 48 hours after the procedure ]
    ileus - surgical emphysema


Eligibility Criteria
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Ages Eligible for Study:   30 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06015698


Contacts
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Contact: Ahmed M Elmaraghy, M.D., 01010370980 amam85@outlook.com
Contact: Ahmed Sewidan, M.D., 01223733849 Ahmed.Sewidan@med.suezuni.edu.eg

Sponsors and Collaborators
Ain Shams Maternity Hospital
Investigators
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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
More Information
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Publications:

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Responsible Party: Ahmed Mohammed Elmaraghy, Lecturer in Obstetrics and Gynecology, Ain Shams Maternity Hospital
ClinicalTrials.gov Identifier: NCT06015698    
Other Study ID Numbers: 10
First Posted: August 29, 2023    Key Record Dates
Last Update Posted: August 29, 2023
Last Verified: August 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infertility
Infertility, Female
Genital Diseases
Urogenital Diseases
 Genital Diseases, Female
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications