Tubal ObstructionNCT04037813
Hysteroscopic Versus Laparoscopic Tubal Occlusion in Cases of Hydrosalpinx and Planning for IVF
A study testing Laparoscopic and hysteroscopic tubal occlusion for hydrosalpinx in people with Tubal Obstruction, run by Cairo University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Tubal Obstruction
- What is being tested?
- Laparoscopic and hysteroscopic tubal occlusion for hydrosalpinx
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Aug 2019to 15 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- Uterine anomalies.
- Serious medical condition and unfit for surgery.
- Contraindication for laparoscopic tubal occlusion.
- Contraindication for pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study of Hysteroscopic Versus Laparoscopic Tubal Occlusion in Cases of Communicating Hydrosalpinx and Planning for IVF
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.
Read the 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.
- Conditions
- Tubal Obstruction
- Being tested
- Laparoscopic and hysteroscopic tubal occlusion for hydrosalpinx
- Keywords
- Hysteroscopy, Laparoscopy, Hydrosalpinx
- Medical subject headings
- Fallopian Tube Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic and hysteroscopic tubal occlusion for hydrosalpinxProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic tubal occlusion | Active comparator | 54 patients will undergo laparoscopic tubal occlusion. Receives: Procedure: Laparoscopic and hysteroscopic tubal occlusion for hydrosalpinx |
| Hysteroscopic tubal occlusion | Active comparator | 54 patients will undergo hysteroscopic tubal occlusion. Receives: Procedure: Laparoscopic and hysteroscopic tubal occlusion for hydrosalpinx |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one month post-operative.
Secondary outcomes (4)
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.
Measured: one month post-operative.
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) .
Measured: 24 hours post-operative.
The operative time and complications in both groups.
the operative time and operative complications will be documented according to the hospital records .
Measured: Intra-operative duration.
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.
Measured: one month post-operative.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2019
- Study start15 Aug 2019
- Primary completion15 Aug 2020
- Study completion15 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tubal ObstructionStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Ahmed Abdel Salam, Cairo University
- Investigators
- Mahmoud A Abdelsalam, Msc, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04037813
- Sponsor's protocol ID
- 140689
- Status last verified
- Feb 2022
- First submitted
- 21 Jul 2019
- Last updated
- 25 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Hysteroscopic Versus Laparoscopic Tubal Occlusion in Cases of Communicating Hydrosalpinx and Planning for IVF
- ClinicalTrials.gov ID
- NCT04037813
- Acronym / sponsor ID
- 140689
- Conditions
- Tubal Obstruction
- Keywords
- Hysteroscopy, Laparoscopy, Hydrosalpinx
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Aug 2019 (actual)
- Primary completion
- 15 Aug 2020 (actual)
- Study completion
- 15 Sep 2020 (actual)
- First posted
- 30 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic tubal occlusion | Active comparator | Procedure: Laparoscopic and hysteroscopic tubal occlusion for hydrosalpinx54 patients will undergo laparoscopic tubal occlusion. |
| Hysteroscopic tubal occlusion | Active comparator | Procedure: Laparoscopic and hysteroscopic tubal occlusion for hydrosalpinx54 patients will undergo hysteroscopic tubal occlusion. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- Uterine anomalies.
- Serious medical condition and unfit for surgery.
- Contraindication for laparoscopic tubal occlusion.
- Contraindication for pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparoscopic and hysteroscopic tubal occlusion for hydrosalpinxFor 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. | Procedure or surgery | Hysteroscopic tubal occlusion, Laparoscopic tubal occlusion |
Primary outcome
The percentage of patients with successful hysteroscopic tubal occlusion
Time frame: one month post-operative.
Successful tubal occlusion will be measured by the presence of negative spill and proximal tubal block on HSG.
4 secondary outcomes
The percentage of patients with successful laparoscopic tubal occlusion
Time frame: one month post-operative.
The post-operative pain in both groups (using VAS ).
Time frame: 24 hours post-operative.
The operative time and complications in both groups.
Time frame: Intra-operative duration.
Compare the success rate of tubal occlusion in both groups.
Time frame: one month post-operative.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2022.
- Individual participant dataSharing planned: No
Related trials for Tubal Obstruction
Recruiting
Effect of Laser Acupoints on Fallopian Tube Obstruction
Laser, Acupoints
Recruiting
Assessment of Tubal Occlusion During Minimally Invasive Myomectomy
Fallopian Tube Patency Tests, Fibroid/Myoma (Uterus/Cervix)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mahmoud A Abdelsalam, Msc principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic and hysteroscopic tubal occlusion for hydrosalpinx in people with Tubal Obstruction, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentage of patients with successful hysteroscopic tubal occlusion (time frame: one month post-operative.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2022.