Prospective randomized trial to evaluate and to compare the impact of hysteroscopic Essure® intratubal device placement and laparoscopic salpingectomy on IVF-ET outcomes of patients with hydrosalpinx.

Subfertile patients with hydrosalpinges have been identified as a subgroup with
significantly poorer outcomes of IVF-ET compared to patients without
hydrosalpinx. Especially patients with hydrosalpinges large enough to be
visible on ultrasound are associated with the the poorest prognosis. The
theories explaining the harmful effect of hydrosalpinges on IVF-ET outcomes are
multiple and include the following: 1. a mechanical washout of the transferred
embryos through tubo-uterine reflux of hydrosalpinx fluid, 2. a direct
embryotoxic effect of the hydrosalpinx fluid 3. a lower endometrial receptivity
as an effect of disturbed expression of the cytokine and integrin system by the
presence of a hydrosalpinx, thus impairing the implantation potential. In the
line of these theories, any surgical intervention interrupting the
communication between hydrosalpinx and uterine cavity would stop the leakage of
hydrosalpinx fluid and improve the endometrial environment for implantation.
Laparoscopic salpingectomy is currently considered the standard treatment for
hydrosalpinx prior to IVF-ET. This is based on a Cochrane systematic review
showing increased odds of ongoing pregnancy and live birth (OR 2.13, 95% CI
1.24-3.65) with laparoscopic salpingectomy for hydrosalpinges prior to IVF-ET.
Laparoscopic salpingectomy prior to IVF-ET in patients with hydrosalpinges
restores IVF outcomes but carries also all the risks associated with operative
intervention and general anaesthesia. Hysteroscopic treatment with essure
devices may form an attractive alternative to laparoscopic treatment of
hydrosalpinx. In contrast to the laparoscopic salpingectomy, the essure
treatment can be performed in an outpatient setting, without use of general
anaesthesia, with shorter procedure times and a quicker recovery time.
Our hypothesis is that hysteroscopic treatment of hydrosalpinges with essure
devices is as effective as laparoscopic salpingectomy with respect to
subsequent IVF-ET outcomes but with less burden and possibly also less
interventional risk for the patient.

1. To evaluate and compare the impact of hysteroscopic Essure® intratubal
device placement and laparoscopic salpingectomy on IVF-ET outcomes of patients
with hydrosalpinx.

2. It is still uncertain whether laparoscopic salpingectomy for hydrosalpinx
may compromise ovarian reserve in women undergoing IVF-ET by partly disrupting
the blood flow to the ovary. In order to evaluate this possible side-effect of
salpingectomy, early follicular phase serum FSH & AMH levels as well as antral
follicle counts will be determined presurgery and 3 months postsurgery in both
the Essure® and the salpingectomy groups.

a multi-centre, prospective, open label, randomized trial.

Laparoscopic salpinectomy versus Hysteroscopic placement of essure devices.

The available data in the literature show very promising results regarding the
effectiveness and safety of hysteroscopic treatment using Essure devices for
hydrosalpinges prior to IVF. In comparison to laparoscopic salpingectomy, the
hysteroscopic treatment can be done in an outpatient setting without general
anesthesia and with a quicker recovery time which is associated with less
burden for patients.
In this trial, 3 visits are included. During visit 1 the patient will undergo
an physical/gynaecological examination, a transvaginal ultrasound scan, an
endometrial biopsy as well as a bloodinvestigation (15 mL). During visit 2 one
of the two asigned treatments (hysteroscopic placement of Essure devices versus
laparoscopic salpingectomy) will be performed. During visit 3 a
bloodinvestigation, a transvaginal ultrasound scan, an endomtrial biopsy and a
hysterosalingography (only for patients who underwent and Essure treatment)
will be performed.