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DESH Trial

 

Dutch Essure versus Salpingectomy for Hydrosalpinx Trial.

 

Indication

Ultrasound visible hydrosalpinges in IVF-ET candidates.

 

Study objectives

The primary objective is to evaluate and compare the impact of hysteroscopic Essure® intratubal device placement (new treatment) and laparoscopic salpingectomy (standard treatment) on IVF-ET outcomes of patients with hydrosalpinx.

Laparoscopic salpingectomy for hydrosalpinx may compromise ovarian reserve in women undergoing IVF-ET by partly disrupting the blood flow to the ovary. Therefore, our secondary objective is to evaluate ovarian reserve through measurements of early follicular phase serum FSH & AMH levels as well as antral follicle counts (transvaginal ultrasound) presurgery and 3 months postsurgery in both study groups.

 

Study population

Female subfertility patients who are candidates for IVF-ET treatment with ultrasound visible hydrosalpinges.

 

Study design

Open, randomized trial.

 

Concurrent control

Laparoscopic salpingectomy (laparoscopic proximal tubal ligation may be performed as an alternative procedure to an intended salpingectomy in patients with extensive pelvic adhesions).

 

Duration of study

Up to the outcome of the first IVF-ET. As legislation and routine practice allow treatment up to 3 IVF-ET cycles and subsequent transfers of frozen-thawed embryos, further follow-up data are anticipated.

 

Primary outcome

Clinical pregnancy rate (defined by the demonstration of fetal heart activity on ultrasound).

 

Secondary outcomes

- Success rate of proximal tubal occlusion with Essure® devices (demonstrated by HSG)

- Complications rate

- Ovarian reserve pre- vs. postsurgery (determined by early follicular serum FSH/AMH as well as antral follicle counts)

 

Total number of patients

80 patients, 40 per group.


Documents

Protocol DESH

Flowchart DESH

Zakkaartje DESH


Trial coordinator

Dr. V. Mijatovic, gynaecologist, Vumc Amsterdam

 

Trial Faculty

Dr. V. Mijatovic, VUmc Amsterdam 
Dr. M.H. Emanuel, Spaarne ziekenhuis Hoofddorp
Dr. R. Schats, VUmc Amsterdam
Dr. P.G.A. Hompes, VUmc Amsterdam