HydrosalpinxNCT04335864
Comparing the Impact of 2 Different Techniques in Management of Hydrosalpinx on Pregnancy Rates Following ICSI
A study testing Laparoscopic salpingectomy and Hystroscopic proximal tubal occlusion in people with Hydrosalpinx, run by Cairo University at 1 site in Egypt.
Trial summary
Assessment and comparing pregnancy outcomes in hydrosalpinx patients treated by hysteroscopic tubal occlusion and laparoscopic salpingectomy before ICSI. 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?
- Laparoscopic salpingectomy and Hystroscopic proximal tubal occlusion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2020to 15 Dec 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 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- primary or secondary infertility cases
- unilateral or bilateral hydrosalpinx proved by HSG (hystersalpingogram) or by TVUS(transvaginal ultrasound) .
Who cannot join
- Uterine factor of infertility
- male factor of infertility
- preexisting ovarian pathology
- Presence of septic focus
- medical or surgical conditions that contraindicated pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Clinical Trial Comparing Laparoscopic Salpingectomy Versus Hysteroscopic Proximal Tubal Occlusion on Pregnancy Rates Following ICSI (Intra-Cytoplasmic Sperm Injection) in Infertile Cases of Hydrosalpinx.
Assessment and comparing pregnancy outcomes in hydrosalpinx patients treated by hysteroscopic tubal occlusion and laparoscopic salpingectomy before ICSI.
Read the detailed description
Hydrosalpinx has a detrimental effect on the rates of implantation, pregnancy and early pregnancy loss following IVF. A meta-analysis demonstrated that the implantation rate and clinical pregnancy rate decreased by 50% in patients with hydrosalpinx. The negative consequences could be due to embryotoxic properties, a decrease in endometrial receptivity, and hydrosalpinx fluid mechanically flushing the embryo from the uterus.
Although laparoscopic salpingectomy and laparoscopic proximal ligation increase ongoing pregnancy rates in women with hydrosalpinges, those interventions are invasive and carry anaesthetic and surgical risks, especially in the presence of extensive adhesions, often seen in women with hydrosalpinges. In view of the possible adverse effects of laparoscopic surgery, an alternative less-invasive treatment for hydrosalpinges prior to IVF would be useful.
The effectiveness of hysteroscopic tubal occlusion when compared with salpingectomy has not been established. Randomized clinical trials comparing both procedures prior to IVF are lacking.
The present study was designed to compare hysteroscopic tubal occlusion and laparoscopic salpingectomy in the treatment of hydrosalpinges prior to IVF.
This study hypothesized that in women scheduled for IVF/ICSI hysteroscopic proximal occlusion of hydrosalpinges would be non-inferior to laparoscopic salpingectomy in terms of ongoing pregnancy rates following IVF/ICSI.
- Conditions
- Hydrosalpinx
- Being tested
- Laparoscopic salpingectomy, Hystroscopic proximal tubal occlusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic salpingectomyProcedure or surgery
39 patients with hydrosalpinx will have laparoscopic salpingectomy
Hystroscopic proximal tubal occlusionProcedure or surgery
39 patients with hydrosalpinx will have hysteroscopic proximal tubal occlusion
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | 39 patients with hydrosalpinx will have laparoscopic salpingectomy Receives: Procedure: Laparoscopic salpingectomy |
| Group B | Active comparator | 39 patients with hydrosalpinx will have hysteroscopic proximal tubal occlusion Receives: Procedure: Hystroscopic proximal tubal occlusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical pregnancy rate following ICSI
Defined as positive qualitative bhcg(beta human chorionic gonadotropin)
Measured: 14 days after Embryo transfer
Secondary outcomes (1)
Ongoing pregnancy following ICSI
Defined as positive fetal heart rate on ultrasound at 8weeks gestation
Measured: 8 weeks after Embryo transfer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2020
- Study start1 Apr 2020
- Primary completion30 Oct 2020
- Study completion15 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shaimaa Mostafa Mohammed Refaay El shemy, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04335864
- Sponsor's protocol ID
- Hydrosalpinx and ICSI
- Status last verified
- Jun 2021
- First submitted
- 29 Mar 2020
- Last updated
- 29 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial Comparing Laparoscopic Salpingectomy Versus Hysteroscopic Proximal Tubal Occlusion on Pregnancy Rates Following ICSI (Intra-Cytoplasmic Sperm Injection) in Infertile Cases of Hydrosalpinx.
- ClinicalTrials.gov ID
- NCT04335864
- Acronym / sponsor ID
- Hydrosalpinx and ICSI
- Conditions
- Hydrosalpinx
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 30 Oct 2020 (actual)
- Study completion
- 15 Dec 2020 (actual)
- First posted
- 6 Apr 2020 (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.
Assessment and comparing pregnancy outcomes in hydrosalpinx patients treated by hysteroscopic tubal occlusion and laparoscopic salpingectomy before ICSI.
Detailed description
Hydrosalpinx has a detrimental effect on the rates of implantation, pregnancy and early pregnancy loss following IVF. A meta-analysis demonstrated that the implantation rate and clinical pregnancy rate decreased by 50% in patients with hydrosalpinx. The negative consequences could be due to embryotoxic properties, a decrease in endometrial receptivity, and hydrosalpinx fluid mechanically flushing the embryo from the uterus.
Although laparoscopic salpingectomy and laparoscopic proximal ligation increase ongoing pregnancy rates in women with hydrosalpinges, those interventions are invasive and carry anaesthetic and surgical risks, especially in the presence of extensive adhesions, often seen in women with hydrosalpinges. In view of the possible adverse effects of laparoscopic surgery, an alternative less-invasive treatment for hydrosalpinges prior to IVF would be useful.
The effectiveness of hysteroscopic tubal occlusion when compared with salpingectomy has not been established. Randomized clinical trials comparing both procedures prior to IVF are lacking.
The present study was designed to compare hysteroscopic tubal occlusion and laparoscopic salpingectomy in the treatment of hydrosalpinges prior to IVF.
This study hypothesized that in women scheduled for IVF/ICSI hysteroscopic proximal occlusion of hydrosalpinges would be non-inferior to laparoscopic salpingectomy in terms of ongoing pregnancy rates following IVF/ICSI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Procedure: Laparoscopic salpingectomy39 patients with hydrosalpinx will have laparoscopic salpingectomy |
| Group B | Active comparator | Procedure: Hystroscopic proximal tubal occlusion39 patients with hydrosalpinx will have hysteroscopic proximal tubal occlusion |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- primary or secondary infertility cases
- unilateral or bilateral hydrosalpinx proved by HSG (hystersalpingogram) or by TVUS(transvaginal ultrasound) .
Key exclusion criteria (5 listed)
- Uterine factor of infertility
- male factor of infertility
- preexisting ovarian pathology
- Presence of septic focus
- medical or surgical conditions that contraindicated 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 salpingectomy39 patients with hydrosalpinx will have laparoscopic salpingectomy | Procedure or surgery | Group A |
| Hystroscopic proximal tubal occlusion39 patients with hydrosalpinx will have hysteroscopic proximal tubal occlusion | Procedure or surgery | Group B |
Primary outcome
Clinical pregnancy rate following ICSI
Time frame: 14 days after Embryo transfer
Defined as positive qualitative bhcg(beta human chorionic gonadotropin)
1 secondary outcome
Ongoing pregnancy following ICSI
Time frame: 8 weeks after Embryo transfer
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 29 Jun 2021.
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.
The record lists no contact. Use the official record to reach the sponsor.
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 salpingectomy and Hystroscopic proximal tubal occlusion 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 2 inclusion and 5 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 29 Jun 2021. 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?
Clinical pregnancy rate following ICSI (time frame: 14 days after Embryo transfer). 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 29 Jun 2021.