Clinical trial NCT03854292: Hydrosalpinx Management Before Intracytoplasmic Sperm Injection
Official title: ICSI Pregnancy Outcomes Following Hysteroscopic Tubal Electrocoagulation Versus Laparoscopic Tubal Disconnection for Patients With Hydrosalpinges
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hydrosalpinx
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-02-26
Enrollment: 50
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 50 patients who have unilateral or bilateral hydrosalpinges identified on hysterosalpingography and vaginal ultrasonography, and who are undergoing IVF.

Brief summary: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: proximal tubal occlusion Success rate .
timeFrame: 15 months
Secondary outcomes:
measure: Pregnancy rate among the two groups.
timeFrame: 15 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
References:
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