Hysteroscopic Versus Laparoscopic Tubal Occlusion in Cases of Hydrosalpinx and Planning for IVF

Tubal Obstruction Clinical Trial

Official title:

Comparative Study of Hysteroscopic Versus Laparoscopic Tubal Occlusion in Cases of Communicating Hydrosalpinx and Planning for IVF

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04037813
• Other study ID #: 140689
• Status: Completed
• Phase: N/A
• Start date: August 15, 2019
• Est. completion date: September 15, 2020

Study information

• Verified date: February 2022
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

compare the efficacy of hysteroscopic tubal occlusion versus laparoscopic tubal occlusion for the patients of communicating hydrosalpinx scheduled for IVF. half of the patients will undergo hysteroscopic tubal occlusion while the other half will undergo laparoscopic tubal occlusion.

Description:

The study will include 108 patients complaining of infertility associated with unilateral or bilateral tubal communicating hydrosalpinx. All the patients will be subjected to informed consent, history taking, full physical examination, ultrasound examination via transvaginal approach using ultrasound machine ( Voluson Pro-V and GE Voluson E 10) and HSG within the last 6 months showing unilateral or bilateral communicating hydrosalpinx.

The patients (108) will be equally randomized into two groups :

Group (A): 54 patients (Hysteroscopic tubal occlusion group). Group (B): 54 patients (Laparoscopic tubal occlusion group). Randomization will be done using 108 opaque sealed envelopes that will be numbered serially from 1-108 and each envelope corresponding letter which denotes the allocated group will be put according to randomization table then all envelopes will be closed and put in one box, when the first patient arrives, after giving informed consent, the first envelope will be opened and the patient will be allocated according to the letter inside.

For hysteroscopic tubal occlusion group it will be done under general anesthesia using standard, rigid 4-mm hysteroscopy with a 30° forward-oblique lens and a 5.5-mm diagnostic sheath (Karl Storz , Germany). Uterine distension allowed a panoramic view of the uterine cavity and identification of the tubal ostia.The roller ball (Ball Electrode, unipolar, 5 Fr) will be used for the coagulation of the interstitial part of the tube and the uterine cornu area.

For laparoscopic tubal occlusion group it will be done under general anesthesia using bipolar coagulation and a proximal tubal cut. The contraindications for laparoscopy were mainly extensive abdominal or pelvic adhesions of various etiologies (e.g. previous surgery, pelvic inflammatory disease, and pelvic endometriosis) and morbid obesity.

The operative details of hysteroscopic tubal occlusion and laparoscopic tubal occlusion including operative time and complications will be documented In both groups, the patients will be followed up for the next 24 hours as regard post-operative pain (using VAS ) and post-operative recovery (patient mobilization, intestinal motility and patient discharge).

The success rate of tubal occlusion will be assessed one month later using post-menstrual HSG and for hysteroscopic group office hysteroscopy will be done for assessment of uterine cavity after electrocoagulation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: September 15, 2020
• Est. primary completion date: August 15, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

Inclusion Criteria:

• Primary or secondary infertility.

• The presence of communicating hydrosalpinx diagnosed by HSG,TV U/S showing distended tubes and intrauterine fluid or patient complaining of prolonged brownish vaginal discharge.

• Candidate for IVF procedure.

Exclusion Criteria:

• Uterine anomalies.

• Serious medical condition and unfit for surgery.

• Contraindication for laparoscopic tubal occlusion.

• Contraindication for pregnancy.

Related Conditions & MeSH terms

• Fallopian Tube Diseases
• Tubal Obstruction

Intervention

Procedure:
• Laparoscopic and hysteroscopic tubal occlusion for hydrosalpinx
For hysteroscopic tubal occlusion group it will be done under general anesthesia using standard, rigid 4-mm hysteroscopy with a 30° forward-oblique lens and a 5.5-mm diagnostic sheath (Karl Storz , Germany). Uterine distension allowed a panoramic view of the uterine cavity and identification of the tubal ostia.The roller ball (Ball Electrode, unipolar, 5 Fr) will be used for the coagulation of the interstitial part of the tube and the uterine cornu area. For laparoscopic tubal occlusion group it will be done under general anesthesia using bipolar coagulation and a proximal tubal cut.

Locations

Country	Name	City	State
Egypt	Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The percentage of patients with successful hysteroscopic tubal occlusion	Successful tubal occlusion will be measured by the presence of negative spill and proximal tubal block on HSG.	one month post-operative.
Secondary	The percentage of patients with successful laparoscopic tubal occlusion	Successful tubal occlusion will be measured by the presence of negative spill and proximal tubal block on HSG.	one month post-operative.
Secondary	The post-operative pain in both groups (using VAS ).	The patients will be followed up for the next 24 hours as regard post-operative pain (using VAS) .	24 hours post-operative.
Secondary	The operative time and complications in both groups.	the operative time and operative complications will be documented according to the hospital records .	Intra-operative duration.
Secondary	Compare the success rate of tubal occlusion in both groups.	The number of HSG that showed post-operative tubal occlusion in hysteroscopic group compared to laparoscopic group.	one month post-operative.