Blocked fallopian tube filled with fluid
Conditions
Interventions
Sponsors
Eligibility
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
| Measure | Time 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
| Measure | Time 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