HydrosalpinxNCT05195073
Three Dimensional Versus Two Dimensional Laparoscopic Salpingectomy in Patients With Hydrosalpinx Undergoing IVF-ET
A study testing Laparoscopy in people with Hydrosalpinx, run by Cairo University at 1 site in Egypt.
Trial summary
A three-dimensional laparoscopic vision system (3-D LVS) has gained acceptance and is being utilized in daily practice despite debates about its success. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Hydrosalpinx
- What is being tested?
- Laparoscopy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2022to 30 Dec 2022
- 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 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Patients with unilateral hydrosalpinx diagnosed with hysterosalpingography or laparoscopy
Who cannot join
- Bilateral hydrosalpinx,
- co-existent adnexal pathology,
- body mass index (BMI) more than 40,
- extensive pelvic adhesions,
- coagulation defects or concurrent anticoagulant therapy,
- compromised cardiopulmonary status,
- and contraindications for general anesthesia.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Three Dimensional Versus Two-dimensional Laparoscopic Salpingectomy in Patients With Hydrosalpinx Undergoing IVF-ET. A Randomized Controlled Trial
A three-dimensional laparoscopic vision system (3-D LVS) has gained acceptance and is being utilized in daily practice despite debates about its success.
Read the detailed description
A three-dimensional laparoscopic vision system (3-D LVS) has gained acceptance and is being utilized in daily practice despite debates about its success. in our study we will compare operative data and early postoperative outcomes of laparoscopic salpingectomy operations conducted using standard 2-D and 3-D laparoscopic vision systems
- Conditions
- Hydrosalpinx
- Being tested
- Laparoscopy
- Keywords
- Hydrosalpinx, Infertility, In vitro fertilization, Laparoscopy
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LaparoscopyBiological
3 D laparoscopy
| Study group | Role | What they receive |
|---|---|---|
| 3 D laparoscopy group | Active comparator | salpingectomy will be performed by using Storz image 1 S 3D laparoscopy system (Karl Storz, Tuttlingen, Germany) which is comprised of a 10 mm scope with 2 full HD sensors at the tip of the scope and a 3 D control unit plus a 3 D display Receives: Biological: Laparoscopy |
| 2 D laparoscopy group | Active comparator | salpingectomy will be performed by using a conventional 2 D laparoscopy system. Receives: Biological: Laparoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The time required to excise the hydrosalpinx
The time required to excise the hydrosalpinx
Measured: 6 months
Secondary outcomes (4)
The degree of difficulty experienced by the surgeon
The degree of difficulty experienced by the surgeon during excision of the hydrosalpinx [ evaluated using a visual analog scale ranging from 0 (least difficult) to 10 (most difficult)].
Measured: 6 months
The total operative time.
The total operative time.
Measured: 6 months
The amount of Intraoperative blood loss.
The amount of Intraoperative blood loss.
Measured: 6 months
Rate of intraoperative and postoperative complications.
Rate of intraoperative and postoperative complications.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2022
- Study start1 Apr 2022
- Primary completion30 Dec 2022
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HydrosalpinxStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa Mohamed Abdalla, Cairo University
- Investigators
- Marwa M Abdalla, Principal investigator, Kasralainy teaching hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05195073
- Sponsor's protocol ID
- 3D Laparoscopic salpingectomy
- Status last verified
- Aug 2023
- First submitted
- 4 Jan 2022
- Last updated
- 16 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fouda UM, Sayed AM. Effect of ultrasound-guided aspiration of hydrosalpingeal fluid during oocyte retrieval on the outcomes of in vitro fertilisation-embryo transfer: a randomised controlled trial (NCT01040351). Gynecol Endocrinol. 2011 Aug;27(8):562-7. doi: 10.3109/09513590.2010.507290. Epub 2010 Jul 30.
PubMed 20672903Strandell A, Lindhard A, Waldenstrom U, Thorburn J, Janson PO, Hamberger L. Hydrosalpinx and IVF outcome: a prospective, randomized multicentre trial in Scandinavia on salpingectomy prior to IVF. Hum Reprod. 1999 Nov;14(11):2762-9. doi: 10.1093/humrep/14.11.2762.
PubMed 10548619Fouda UM, Sayed AM, Abdelmoty HI, Elsetohy KA. Ultrasound guided aspiration of hydrosalpinx fluid versus salpingectomy in the management of patients with ultrasound visible hydrosalpinx undergoing IVF-ET: a randomized controlled trial. BMC Womens Health. 2015;15:21. doi: 10.1186/s12905-015-0177-2. Epub 2015 Feb 27.
PubMed 25783650Johnson N, van Voorst S, Sowter MC, Strandell A, Mol BW. Surgical treatment for tubal disease in women due to undergo in vitro fertilisation. Cochrane Database Syst Rev. 2010 Jan 20;2010(1):CD002125. doi: 10.1002/14651858.CD002125.pub3.
PubMed 20091531Fouda UM, Elsetohy KA, Elshaer HS. Barbed Versus Conventional Suture: A Randomized Trial for Suturing the Endometrioma Bed After Laparoscopic Excision of Ovarian Endometrioma. J Minim Invasive Gynecol. 2016 Sep-Oct;23(6):962-8. doi: 10.1016/j.jmig.2016.06.008. Epub 2016 Jun 18.
PubMed 27329547
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Three Dimensional Versus Two-dimensional Laparoscopic Salpingectomy in Patients With Hydrosalpinx Undergoing IVF-ET. A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05195073
- Acronym / sponsor ID
- 3D Laparoscopic salpingectomy
- Conditions
- Hydrosalpinx
- Keywords
- Hydrosalpinx, Infertility, In vitro fertilization, Laparoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 18 Jan 2022 (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.
A three-dimensional laparoscopic vision system (3-D LVS) has gained acceptance and is being utilized in daily practice despite debates about its success.
Detailed description
A three-dimensional laparoscopic vision system (3-D LVS) has gained acceptance and is being utilized in daily practice despite debates about its success. in our study we will compare operative data and early postoperative outcomes of laparoscopic salpingectomy operations conducted using standard 2-D and 3-D laparoscopic vision systems
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3 D laparoscopy group | Active comparator | Biological: Laparoscopysalpingectomy will be performed by using Storz image 1 S 3D laparoscopy system (Karl Storz, Tuttlingen, Germany) which is comprised of a 10 mm scope with 2 full HD sensors at the tip of the scope and a 3 D control unit plus a 3 D display |
| 2 D laparoscopy group | Active comparator | Biological: Laparoscopysalpingectomy will be performed by using a conventional 2 D laparoscopy system. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients with unilateral hydrosalpinx diagnosed with hysterosalpingography or laparoscopy
Key exclusion criteria (7 listed)
- Bilateral hydrosalpinx,
- co-existent adnexal pathology,
- body mass index (BMI) more than 40,
- extensive pelvic adhesions,
- coagulation defects or concurrent anticoagulant therapy,
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 |
|---|---|---|
| Laparoscopy3 D laparoscopy | Biological | 2 D laparoscopy group, 3 D laparoscopy group |
Primary outcome
The time required to excise the hydrosalpinx
Time frame: 6 months
The time required to excise the hydrosalpinx
4 secondary outcomes
The degree of difficulty experienced by the surgeon
Time frame: 6 months
The total operative time.
Time frame: 6 months
The amount of Intraoperative blood loss.
Time frame: 6 months
Rate of intraoperative and postoperative complications.
Time frame: 6 months
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 16 Aug 2023.
- Background: PubMed 20672903Fouda UM, Sayed AM. Effect of ultrasound-guided aspiration of hydrosalpingeal fluid during oocyte retrieval on the outcomes of in vitro fertilisation-embryo transfer: a randomised controlled trial (NCT01040351). Gynecol Endocrinol. 2011 Aug;27(8):562-7. doi: 10.3109/09513590.2010.507290. Epub 2010 Jul 30.
- Background: PubMed 10548619Strandell A, Lindhard A, Waldenstrom U, Thorburn J, Janson PO, Hamberger L. Hydrosalpinx and IVF outcome: a prospective, randomized multicentre trial in Scandinavia on salpingectomy prior to IVF. Hum Reprod. 1999 Nov;14(11):2762-9. doi: 10.1093/humrep/14.11.2762.
- Background: PubMed 25783650Fouda UM, Sayed AM, Abdelmoty HI, Elsetohy KA. Ultrasound guided aspiration of hydrosalpinx fluid versus salpingectomy in the management of patients with ultrasound visible hydrosalpinx undergoing IVF-ET: a randomized controlled trial. BMC Womens Health. 2015;15:21. doi: 10.1186/s12905-015-0177-2. Epub 2015 Feb 27.
- Background: PubMed 20091531Johnson N, van Voorst S, Sowter MC, Strandell A, Mol BW. Surgical treatment for tubal disease in women due to undergo in vitro fertilisation. Cochrane Database Syst Rev. 2010 Jan 20;2010(1):CD002125. doi: 10.1002/14651858.CD002125.pub3.
- Background: PubMed 27329547Fouda UM, Elsetohy KA, Elshaer HS. Barbed Versus Conventional Suture: A Randomized Trial for Suturing the Endometrioma Bed After Laparoscopic Excision of Ovarian Endometrioma. J Minim Invasive Gynecol. 2016 Sep-Oct;23(6):962-8. doi: 10.1016/j.jmig.2016.06.008. Epub 2016 Jun 18.
- Individual participant dataSharing planned: No
Related trials for Hydrosalpinx
Recruiting
Comprehensive Assessment System for Fallopian Tube Function and Clinical Study on Individualized Treatment Strategies
Multidimensional Tubal Function Assessment and Individualized Treatment Strategies for Tubal Factor Infertility
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.
Marwa M Abdalla principal investigator
Kasralainy teaching hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopy in people with Hydrosalpinx, 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 1 inclusion and 7 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 16 Aug 2023. 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 time required to excise the hydrosalpinx (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05195073, which also lists 5 linked publications.
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 16 Aug 2023.