Laparoscopic Tubal Disconnection Versus Laparoscopic Salpingectomy in Infertile Patients

NCT06015698 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2023-08-29

No results posted yet for this study

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.

Conditions

  • Infertility, Female

Interventions

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

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

Sponsors & Collaborators

  • Ain Shams Maternity Hospital

    lead OTHER

Principal Investigators

  • Hamdy B Alqenawy, M.D., · Ain Shams university - Faculty of Medicine

  • Ahmed G Abd Elrahim, M.D., · Ain Shams university - Faculty of Medicine

  • Alaa S Elsewafy, M.D., · Ain Shams university - Faculty of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-30
Primary Completion
2024-08-30
Completion
2024-08-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06015698 on ClinicalTrials.gov