Clinical trial NCT04037813: Hysteroscopic Versus Laparoscopic Tubal Occlusion in Cases of Hydrosalpinx and Planning for IVF
Official title: Comparative Study of Hysteroscopic Versus Laparoscopic Tubal Occlusion in Cases of Communicating Hydrosalpinx and Planning for IVF
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tubal Obstruction
Keywords: Hysteroscopy
Laparoscopy
Hydrosalpinx
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-07-30
Enrollment: 108
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: The percentage of patients with successful hysteroscopic tubal occlusion
timeFrame: one month post-operative.
Secondary outcomes:
measure: The percentage of patients with successful laparoscopic tubal occlusion
timeFrame: one month post-operative.
measure: The post-operative pain in both groups (using VAS ).
timeFrame: 24 hours post-operative.
measure: The operative time and complications in both groups.
timeFrame: Intra-operative duration.
measure: Compare the success rate of tubal occlusion in both groups.
timeFrame: one month post-operative.
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
affiliation: Cairo University
name: Mahmoud A Abdelsalam, Msc
role: PRINCIPAL_INVESTIGATOR
References: