HydrosalpinxNCT03854292
Hydrosalpinx Management Before Intracytoplasmic Sperm Injection
An observational study of Hydrosalpinx, run by Cairo University at 1 site in Egypt.
Trial summary
ICSI pregnancy outcomes following hysteroscopic tubal electrocoagulation versus laparoscopic tubal disconnection for patients with hydrosalpinges Read more about this study
- Who is it for?
- Ages 20 to 35 years, women only
- Conditions the study is for
- Hydrosalpinx
- What is being tested?
- Hysteroscopic tubal electrocoagulation
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2017to 31 May 2018
- Phase
- Observational
- 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 35 years
- Women only
- No healthy volunteers
- Adult
Study population: 50 patients who have unilateral or bilateral hydrosalpinges identified on hysterosalpingography and vaginal ultrasonography, and who are undergoing IVF.
Who may be able to join
- Age from 20 to 35 years
- Primary or secondary infertility.
- Diagnosis of hydrosalpinx; diagnosed by HSG and TV U/S.
- Necessity of an IVF procedure.
Who cannot join
- Patients with uterine factor infertility.
- Medical or surgical conditions contraindicating pregnancy.
- Poor responders according to reference criteria.
- Cases of polycystic ovary disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: ICSI Pregnancy Outcomes Following Hysteroscopic Tubal Electrocoagulation Versus Laparoscopic Tubal Disconnection for Patients With Hydrosalpinges
ICSI pregnancy outcomes following hysteroscopic tubal electrocoagulation versus laparoscopic tubal disconnection for patients with hydrosalpinges
Read the detailed description
Tubal factor of infertility resulting from various forms of tuboperitoneal damage remains an extremely common cause of female infertility, accounting for more than 35% of all cases of female infertility. Probably the most severe form of tubal pathology is hydrosalpinx. Hydrosalpinx is a Greek word that means a Fallopian tube filled with water or fluid. Patients with hydrosalpinges have been identified as a subgroup with significantly lower implantation and pregnancy rates than patients with other tubal pathologies. An increased risk for early pregnancy loss and increased risk for ectopic pregnancies was reported, and many studies confirmed that the presence of hydrosalpinx significantly impairs in vitro fertilization (IVF) outcome as well.
Patients with a hydrosalpinx have been found to have significantly poorer outcomes of IVF than do patients with tubal factor infertility but no hydrosalpinx .
Hydrosalpinges in infertile women reduce the success of IVF by 50 % .
The harmful effect of a hydrosalpinx on pregnancy rates after IVF has been attributed to mechanical washout of the transferred embryos by tubal-uterine reflux of the hydrosalpinx fluid .
Additionally, a hydrosalpinx might disturb endometrial receptivity: integrins, the best endometrial markers, show decreased expression in cases of hydrosalpinx .
Altered endometrial blood flow has also been proposed as a possible factor causing decreased rates of implantation.
Any surgical interventions that disrupt tubal-uterine communication in affected tubes might improve pregnancy rates .
Laparoscopic salpingectomy was the most popular treatment option offered by the clinicians, followed by open salpingectomy, salpingostomy, proximal tubal occlusion and transvaginal ultrasonographic guided hydrosalpinx aspiration either before or during oocyte retrieval.The latest treatment option introduced was proximal occlusion of the hydrosalpinx by hysteroscopic placement of microinserts. Clinicians would still perform open salpingectomy. The possible explanation for this could be the lack of training in endoscopic surgery and/or that patients with tubal disease may have significant pelvic adhesions necessitating open surgery.
Laparoscopic salpingectomy or tubal ligation has been shown to improve IVF outcomes for patients with a hydrosalpinx.
However, this procedure has many drawbacks, including its invasiveness, the possibility of surgical injury (e.g. visceral injury, vascular damage, or unintended laparotomy), the potential risks from general anesthesia, and technical difficulty if there are pelvic adhesions .
The proximal occlusion of a hydrosalpinx by hysteroscopy might offer a feasible therapeutic alternative when laparoscopy is technically difficult or contraindicated,with the advantage of hysteroscopic procedures of faster recovery, less hospitalization and rapid return to work, and in the future it might be done in the outpatient clinic as an office procedure.
- Conditions
- Hydrosalpinx
- Being tested
- Hysteroscopic tubal electrocoagulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hysteroscopic tubal electrocoagulationProcedure or surgery
Unilateral or bilateral electrocoagulation of the cornual end of the tube and the surrounding part of the uterine horn was performed using a hysteroscopicelectrocoagulating roller ball.
| Study group | Role | What they receive |
|---|---|---|
| Hysteroscopic tubal electrocoagulation | Unilateral or bilateral electrocoagulation of the cornual end of the tube and the surrounding part of the uterine horn was performed using a hysteroscopic electrocoagulating roller ball Receives: Procedure: Hysteroscopic tubal electrocoagulation | |
| Laparoscopic tubal disconnection | Coagulation of the mid isthmus region of the affected Fallopian tube, with the bipolar forceps. using direct current that was no greater than 25 Watts. Receives: Procedure: Hysteroscopic tubal electrocoagulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
proximal tubal occlusion Success rate .
proximal tubal occlusion Success rate among two groups detected by Hysterosalpingogram.
Measured: 15 months
Secondary outcomes (1)
Pregnancy rate among the two groups.
Chemical Pregnancy rate among the two groups.
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2019
- Study start1 Mar 2017
- Primary completion31 May 2018
- Study completion31 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa Mohamed Abdalla, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03854292
- Sponsor's protocol ID
- tubal disconnection
- Status last verified
- Jul 2019
- First submitted
- 23 Feb 2019
- Last updated
- 15 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Strandell A, Waldenstrom U, Nilsson L, Hamberger L. Hydrosalpinx reduces in-vitro fertilization/embryo transfer pregnancy rates. Hum Reprod. 1994 May;9(5):861-3. doi: 10.1093/oxfordjournals.humrep.a138606.
PubMed 7929732Strandell 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 10548619Puttemans P, Campo R, Gordts S, Brosens I. Hydrosalpinx and ART: hydrosalpinx--functional surgery or salpingectomy? Hum Reprod. 2000 Jul;15(7):1427-30. doi: 10.1093/humrep/15.7.1427.
PubMed 10875845Mijatovic V, Veersema S, Emanuel MH, Schats R, Hompes PG. Essure hysteroscopic tubal occlusion device for the treatment of hydrosalpinx prior to in vitro fertilization-embryo transfer in patients with a contraindication for laparoscopy. Fertil Steril. 2010 Mar 1;93(4):1338-42. doi: 10.1016/j.fertnstert.2008.11.022. Epub 2009 Jan 14.
PubMed 19147140Savaris RF, Pedrini JL, Flores R, Fabris G, Zettler CG. Expression of alpha 1 and beta 3 integrins subunits in the endometrium of patients with tubal phimosis or hydrosalpinx. Fertil Steril. 2006 Jan;85(1):188-92. doi: 10.1016/j.fertnstert.2005.06.039.
PubMed 16412752Hammadieh N, Afnan M, Evans J, Sharif K, Amso N, Olufowobi O. A postal survey of hydrosalpinx management prior to IVF in the United Kingdom. Hum Reprod. 2004 Apr;19(4):1009-12. doi: 10.1093/humrep/deh133. Epub 2004 Mar 11.
PubMed 15016787Kontoravdis A, Makrakis E, Pantos K, Botsis D, Deligeoroglou E, Creatsas G. Proximal tubal occlusion and salpingectomy result in similar improvement in in vitro fertilization outcome in patients with hydrosalpinx. Fertil Steril. 2006 Dec;86(6):1642-9. doi: 10.1016/j.fertnstert.2006.05.032. Epub 2006 Oct 25.
PubMed 17069813El-Mazny A, Abou-Salem N, Hammam M, Saber W. Hysteroscopic tubal electrocoagulation versus laparoscopic tubal ligation for patients with hydrosalpinges undergoing in vitro fertilization. Int J Gynaecol Obstet. 2015 Sep;130(3):250-2. doi: 10.1016/j.ijgo.2015.04.039. Epub 2015 Jul 2.
PubMed 26140948Parihar M, Mirge A, Hasabe R. Hydrosalpinx functional surgery or salpingectomy? The importance of hydrosalpinx fluid in assisted reproductive technologies. J Gynecol Endosc Surg. 2009 Jan;1(1):12-6. doi: 10.4103/0974-1216.51903.
PubMed 22442504Stadtmauer LA, Riehl RM, Toma SK, Talbert LM. Cauterization of hydrosalpinges before in vitro fertilization is an effective surgical treatment associated with improved pregnancy rates. Am J Obstet Gynecol. 2000 Aug;183(2):367-71. doi: 10.1067/mob.2000.107671.
PubMed 10942471
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ICSI Pregnancy Outcomes Following Hysteroscopic Tubal Electrocoagulation Versus Laparoscopic Tubal Disconnection for Patients With Hydrosalpinges
- ClinicalTrials.gov ID
- NCT03854292
- Acronym / sponsor ID
- tubal disconnection
- Conditions
- Hydrosalpinx
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 31 May 2018 (actual)
- Study completion
- 31 May 2018 (actual)
- First posted
- 26 Feb 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.
ICSI pregnancy outcomes following hysteroscopic tubal electrocoagulation versus laparoscopic tubal disconnection for patients with hydrosalpinges
Detailed description
Tubal factor of infertility resulting from various forms of tuboperitoneal damage remains an extremely common cause of female infertility, accounting for more than 35% of all cases of female infertility. Probably the most severe form of tubal pathology is hydrosalpinx. Hydrosalpinx is a Greek word that means a Fallopian tube filled with water or fluid. Patients with hydrosalpinges have been identified as a subgroup with significantly lower implantation and pregnancy rates than patients with other tubal pathologies. An increased risk for early pregnancy loss and increased risk for ectopic pregnancies was reported, and many studies confirmed that the presence of hydrosalpinx significantly impairs in vitro fertilization (IVF) outcome as well.
Patients with a hydrosalpinx have been found to have significantly poorer outcomes of IVF than do patients with tubal factor infertility but no hydrosalpinx .
Hydrosalpinges in infertile women reduce the success of IVF by 50 % .
The harmful effect of a hydrosalpinx on pregnancy rates after IVF has been attributed to mechanical washout of the transferred embryos by tubal-uterine reflux of the hydrosalpinx fluid .
Additionally, a hydrosalpinx might disturb endometrial receptivity: integrins, the best endometrial markers, show decreased expression in cases of hydrosalpinx .
Altered endometrial blood flow has also been proposed as a possible factor causing decreased rates of implantation.
Any surgical interventions that disrupt tubal-uterine communication in affected tubes might improve pregnancy rates .
Laparoscopic salpingectomy was the most popular treatment option offered by the clinicians, followed by open salpingectomy, salpingostomy, proximal tubal occlusion and transvaginal ultrasonographic guided hydrosalpinx aspiration either before or during oocyte retrieval.The latest treatment option introduced was proximal occlusion of the hydrosalpinx by hysteroscopic placement of microinserts. Clinicians would still perform open salpingectomy. The possible explanation for this could be the lack of training in endoscopic surgery and/or that patients with tubal disease may have significant pelvic adhesions necessitating open surgery.
Laparoscopic salpingectomy or tubal ligation has been shown to improve IVF outcomes for patients with a hydrosalpinx.
However, this procedure has many drawbacks, including its invasiveness, the possibility of surgical injury (e.g. visceral injury, vascular damage, or unintended laparotomy), the potential risks from general anesthesia, and technical difficulty if there are pelvic adhesions .
The proximal occlusion of a hydrosalpinx by hysteroscopy might offer a feasible therapeutic alternative when laparoscopy is technically difficult or contraindicated,with the advantage of hysteroscopic procedures of faster recovery, less hospitalization and rapid return to work, and in the future it might be done in the outpatient clinic as an office procedure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hysteroscopic tubal electrocoagulation | – | Procedure: Hysteroscopic tubal electrocoagulationUnilateral or bilateral electrocoagulation of the cornual end of the tube and the surrounding part of the uterine horn was performed using a hysteroscopic electrocoagulating roller ball |
| Laparoscopic tubal disconnection | – | Procedure: Hysteroscopic tubal electrocoagulationCoagulation of the mid isthmus region of the affected Fallopian tube, with the bipolar forceps. using direct current that was no greater than 25 Watts. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- 50 patients who have unilateral or bilateral hydrosalpinges identified on hysterosalpingography and vaginal ultrasonography, and who are undergoing IVF.
Key inclusion criteria (4 listed)
- Age from 20 to 35 years
- Primary or secondary infertility.
- Diagnosis of hydrosalpinx; diagnosed by HSG and TV U/S.
- Necessity of an IVF procedure.
Key exclusion criteria (4 listed)
- Patients with uterine factor infertility.
- Medical or surgical conditions contraindicating pregnancy.
- Poor responders according to reference criteria.
- Cases of polycystic ovary disease.
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 |
|---|---|---|
| Hysteroscopic tubal electrocoagulationUnilateral or bilateral electrocoagulation of the cornual end of the tube and the surrounding part of the uterine horn was performed using a hysteroscopicelectrocoagulating roller ball. | Procedure or surgery | Hysteroscopic tubal electrocoagulation, Laparoscopic tubal disconnection |
Primary outcome
proximal tubal occlusion Success rate .
Time frame: 15 months
proximal tubal occlusion Success rate among two groups detected by Hysterosalpingogram.
1 secondary outcome
Pregnancy rate among the two groups.
Time frame: 15 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 15 Jul 2019.
- Background: PubMed 7929732Strandell A, Waldenstrom U, Nilsson L, Hamberger L. Hydrosalpinx reduces in-vitro fertilization/embryo transfer pregnancy rates. Hum Reprod. 1994 May;9(5):861-3. doi: 10.1093/oxfordjournals.humrep.a138606.
- 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 10875845Puttemans P, Campo R, Gordts S, Brosens I. Hydrosalpinx and ART: hydrosalpinx--functional surgery or salpingectomy? Hum Reprod. 2000 Jul;15(7):1427-30. doi: 10.1093/humrep/15.7.1427.
- Background: PubMed 19147140Mijatovic V, Veersema S, Emanuel MH, Schats R, Hompes PG. Essure hysteroscopic tubal occlusion device for the treatment of hydrosalpinx prior to in vitro fertilization-embryo transfer in patients with a contraindication for laparoscopy. Fertil Steril. 2010 Mar 1;93(4):1338-42. doi: 10.1016/j.fertnstert.2008.11.022. Epub 2009 Jan 14.
- Background: PubMed 16412752Savaris RF, Pedrini JL, Flores R, Fabris G, Zettler CG. Expression of alpha 1 and beta 3 integrins subunits in the endometrium of patients with tubal phimosis or hydrosalpinx. Fertil Steril. 2006 Jan;85(1):188-92. doi: 10.1016/j.fertnstert.2005.06.039.
- Background: PubMed 15016787Hammadieh N, Afnan M, Evans J, Sharif K, Amso N, Olufowobi O. A postal survey of hydrosalpinx management prior to IVF in the United Kingdom. Hum Reprod. 2004 Apr;19(4):1009-12. doi: 10.1093/humrep/deh133. Epub 2004 Mar 11.
- Background: PubMed 17069813Kontoravdis A, Makrakis E, Pantos K, Botsis D, Deligeoroglou E, Creatsas G. Proximal tubal occlusion and salpingectomy result in similar improvement in in vitro fertilization outcome in patients with hydrosalpinx. Fertil Steril. 2006 Dec;86(6):1642-9. doi: 10.1016/j.fertnstert.2006.05.032. Epub 2006 Oct 25.
- Background: PubMed 26140948El-Mazny A, Abou-Salem N, Hammam M, Saber W. Hysteroscopic tubal electrocoagulation versus laparoscopic tubal ligation for patients with hydrosalpinges undergoing in vitro fertilization. Int J Gynaecol Obstet. 2015 Sep;130(3):250-2. doi: 10.1016/j.ijgo.2015.04.039. Epub 2015 Jul 2.
- Background: PubMed 22442504Parihar M, Mirge A, Hasabe R. Hydrosalpinx functional surgery or salpingectomy? The importance of hydrosalpinx fluid in assisted reproductive technologies. J Gynecol Endosc Surg. 2009 Jan;1(1):12-6. doi: 10.4103/0974-1216.51903.
- Background: PubMed 10942471Stadtmauer LA, Riehl RM, Toma SK, Talbert LM. Cauterization of hydrosalpinges before in vitro fertilization is an effective surgical treatment associated with improved pregnancy rates. Am J Obstet Gynecol. 2000 Aug;183(2):367-71. doi: 10.1067/mob.2000.107671.
- 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.
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?
An observational study of 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 4 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 15 Jul 2019. 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?
proximal tubal occlusion Success rate . (time frame: 15 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 NCT03854292, which also lists 10 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 15 Jul 2019.