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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.

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. - The DESH (Dutch Essure® versus Salpingectomy for Hydrosalpinx) Trial.

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON39635
Enrollment
80
Registered
2009-08-21
Start date
2009-09-01
Completion date
Unknown
Last updated
2024-11-18

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

Conditions

Blocked fallopian tube filled with fluid

Interventions

Laparoscopic salpinectomy versus Hysteroscopic placement of essure devices.

Sponsors

Vrije Universiteit Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Presence of uni- or bilateral hydrosalpinges (established with transvaginal ultrasouns) - Female age

Exclusion criteria

Exclusion criteria: - Female age > 40 years at the time of randomization - Pregnancy or suspected pregnancy - Recent or active pelvic infection - Evidence of proximal tubal occlusion in the hydrosalpinx seen at HSG or at laparoscopy - Patient not suitable for IVF-ET - Patient not suitable for laparoscopic surgery

Design outcomes

Primary

MeasureTime frame
• Live birth rate • Clinical pregnancy rate (defined by the demonstration of fetal heart activity on ultrasound). • Success rate of proximal tubal occlusion with Essure® devices (demonstrated by HSG)

Secondary

MeasureTime frame
• Miscarriage rate • Implantation rate (defined as number of gestational sacs on ultrasound/ number of embryo*s transferred) • Ectopic pregnancy rate • Multiple pregnancy rate • Complications rate • Ovarian reserve pre- vs. postsurgery (determined by early follicular serum FSH/AMH as well as antral follicle counts) • Change in endometrial receptivity, determined by endometrial biopsy once before treastment of the hydrosalpinx and the second 12 weeks post treatment. Endometrial receptivity will be examined by measuring the gene expression in the biopsies and by histological dating of the biopsies.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)