Essure® intratubal device placement for Hydrosalpinx in patients undrgoing IVF treatment. A randomized comparison with laparoscopic removal of the hydrosalpinx.

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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON24394

Enrollment

Registered

2009-10-21

Start date

2009-09-24

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hydrosalpinx, IVF, Essure, Laparoscopy, salpingectomy

Interventions

Essure® intratubal device placement (new treatment) and laparoscopic salpingectomy (standard treatment) on IVF-ET outcomes of patients with hydrosalpinx.

Eligibility

Inclusion criteria

Inclusion criteria: 1. Presence of uni- or bilateral hydrosalpinges prior to IVF-ET. A hydrosalpinx is defined as: a distally occluded fallopian tube which was pathologically dilated or became pathologically dilated when patency was tested by hysterosalpingography and/or laparoscopy. The hydrosalpinx should be visible on ultrasound performed midcyclically as these have been associated with the poorest prognosis regarding IVF-ET outcomes [5]; 2. Female age ¡Ü 40 years at the time of randomization; 3. Patient suitable for IVF-ET treatment; 4. Patient suitable for laparoscopic surgery; 5. Concomitant male factor requiring intracytoplasmatic sperm injection (ICSI) is accepted provided that a centre has an established ICSI programme with results equivalent to conventional IVF.

Exclusion criteria

Exclusion criteria: 1. Female age > 40 years at the time of randomization; 2. Pregnancy or suspected pregnancy; 3. Recent or active pelvic infection; 4. Previous tubal ligation; 5. Evidence of proximal tubal occlusion in the hydrosalpinx seen at HSG or at laparoscopy; 6. Patient not suitable for IVF-ET; 7. Patient not suitable for laparoscopic surgery; 8. Concomitant male factor not suitable for ICSI; 9. Uterine fibroids interfering with IVF-ET, ICSI or placement of Essure ® devices; 10. Presence of any malignancy.

Design outcomes

Primary

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

Secondary

Measure	Time frame
1. Success rate of proximal tubal occlusion with Essure® devices (demonstrated by HSG); 2. Miscarriage rate; 3. Implantation rate (defined as number of gestational sacs on ultrasound/ number of embryo¡¯s transferred); 4. Ectopic pregnancy rate; 5. Multiple pregnancy rate; 6. Complications rate; 7. Ovarian reserve pre- vs. postsurgery (determined by early follicular serum FSH/AMH as well as antral follicle counts).	—

Measure

Time frame

1. Success rate of proximal tubal occlusion with Essure® devices (demonstrated by HSG); 2. Miscarriage rate; 3. Implantation rate (defined as number of gestational sacs on ultrasound/ number of embryo¡¯s transferred); 4. Ectopic pregnancy rate; 5. Multiple pregnancy rate; 6. Complications rate; 7. Ovarian reserve pre- vs. postsurgery (determined by early follicular serum FSH/AMH as well as antral follicle counts).

—

Contacts

Public ContactV. Mijatovic

mijatovic@vumc.nl+31 (0)20 4440070

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)