- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03854292
Hydrosalpinx Management Before Intracytoplasmic Sperm Injection
ICSI Pregnancy Outcomes Following Hysteroscopic Tubal Electrocoagulation Versus Laparoscopic Tubal Disconnection for Patients With Hydrosalpinges
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Cairo, Egypt
- Cairo University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Patients with uterine factor infertility.
- Medical or surgical conditions contraindicating pregnancy.
- Poor responders according to reference criteria.
- Cases of polycystic ovary disease.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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
|
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.
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
proximal tubal occlusion Success rate .
Time Frame: 15 months
|
proximal tubal occlusion Success rate among two groups detected by Hysterosalpingogram.
|
15 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pregnancy rate among the two groups.
Time Frame: 15 months
|
Chemical Pregnancy rate among the two groups.
|
15 months
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Savaris 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.
- Strandell 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.
- 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.
- Puttemans 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.
- Mijatovic 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.
- Hammadieh 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.
- Kontoravdis 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.
- El-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.
- Parihar 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.
- Stadtmauer 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- tubal disconnection
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hydrosalpinx
-
Wenzhou Medical UniversityUnknown
-
Ain Shams UniversityNot yet recruitingEffectiveness of Isoamyl-2-cyanoacrylate With and Without Ethiodized Oil in Occluding Hydrosalpinx Prior to IVF
-
Cairo UniversityCompleted
-
Cairo UniversityCompleted
-
Reproductive Science CenterUnknownWomen Suffering From Unilateral or Bilateral Tubal Occlusion Due to HydrosalpinxUnited States
-
Ain Shams UniversityUnknownInfertility, Female | HydrosalpinxEgypt
-
ShangHai Ji Ai Genetics & IVF InstituteWithdrawn
-
Reproductive Science CenterShady Grove FertilityCompletedWomen Who Suffer From Hydrosalpinx That is Causing Infertility and Whom Want a Safer Way of TreamtentUnited States
-
University of BirminghamTommy'sCompletedMiscarriage, Recurrent | Abortion, Spontaneous | HydrosalpinxUnited Kingdom
-
Lebanese UniversityCompletedPolycystic Ovary Syndrome | Endometriosis | Ectopic Pregnancy | Premature Ovarian Failure | Female Infertility Endocrine | Female Infertility | Fibroids | Salpingitis | Hydrosalpinx | Female Infertility Due to Ovulatory Disorder | Female Infertility of Tubal Origin | Female Infertility Due to Tubal Block | Female... and other conditionsLebanon
Clinical Trials on Hysteroscopic tubal electrocoagulation
-
BayerCompleted
-
Woman's Health University Hospital, EgyptRecruitingTubal Patency and Peristalsis During HysteroscopyEgypt
-
Medical University of ViennaUniversity of Mississippi Medical CenterCompletedInfertility, Female | Infertility of Tubal Origin | Fallopian Tube Occlusion | Uterus AbnormalAustria
-
Woman's Health University Hospital, EgyptCompletedFallopian Tube Peristalsis and Patency | Endometrial PatternEgypt
-
Cairo UniversityCompletedTubal ObstructionEgypt
-
Sun Yat-sen UniversityUnknownRetinal DetachmentChina
-
Iuliu Hatieganu University of Medicine and PharmacyRecruiting
-
University Hospital, Strasbourg, FranceCompletedEndometrial PolypsFrance
-
Instituto Dante Pazzanese de CardiologiaUnknown