Hydrosalpinx
Conditions
Brief summary
Assessment and comparing pregnancy outcomes in hydrosalpinx patients treated by hysteroscopic tubal occlusion and laparoscopic salpingectomy before ICSI.
Detailed description
Hydrosalpinx has a detrimental effect on the rates of implantation, pregnancy and early pregnancy loss following IVF. A meta-analysis demonstrated that the implantation rate and clinical pregnancy rate decreased by 50% in patients with hydrosalpinx. The negative consequences could be due to embryotoxic properties, a decrease in endometrial receptivity, and hydrosalpinx fluid mechanically flushing the embryo from the uterus. Although laparoscopic salpingectomy and laparoscopic proximal ligation increase ongoing pregnancy rates in women with hydrosalpinges, those interventions are invasive and carry anaesthetic and surgical risks, especially in the presence of extensive adhesions, often seen in women with hydrosalpinges. In view of the possible adverse effects of laparoscopic surgery, an alternative less-invasive treatment for hydrosalpinges prior to IVF would be useful. The effectiveness of hysteroscopic tubal occlusion when compared with salpingectomy has not been established. Randomized clinical trials comparing both procedures prior to IVF are lacking. The present study was designed to compare hysteroscopic tubal occlusion and laparoscopic salpingectomy in the treatment of hydrosalpinges prior to IVF. This study hypothesized that in women scheduled for IVF/ICSI hysteroscopic proximal occlusion of hydrosalpinges would be non-inferior to laparoscopic salpingectomy in terms of ongoing pregnancy rates following IVF/ICSI.
Interventions
PROCEDURELaparoscopic salpingectomy
39 patients with hydrosalpinx will have laparoscopic salpingectomy
PROCEDUREHystroscopic proximal tubal occlusion
39 patients with hydrosalpinx will have hysteroscopic proximal tubal occlusion
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* primary or secondary infertility cases * unilateral or bilateral hydrosalpinx proved by HSG (hystersalpingogram) or by TVUS(transvaginal ultrasound) .
Exclusion criteria
* Uterine factor of infertility * male factor of infertility * preexisting ovarian pathology * Presence of septic focus * medical or surgical conditions that contraindicated pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical pregnancy rate following ICSI | 14 days after Embryo transfer | Defined as positive qualitative bhcg(beta human chorionic gonadotropin) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ongoing pregnancy following ICSI | 8 weeks after Embryo transfer | Defined as positive fetal heart rate on ultrasound at 8weeks gestation |
Countries
Egypt
Outcome results
None listed