Infertility
Conditions
Keywords
Infertility, Hydrosalpinx, IVF-ET, Salpingectomy
Brief summary
The aim of this randomized controlled trial is to compare the efficacy of ultrasound guided aspiration of hydrosalpingeal fluid with salpingectomy in the management patients with ultrasound visible hydrosalpinges undergoing IVF-ET.
Detailed description
The adverse impact of hydrosalpinx on in vitro fertilisation embryo transfer (IVF-ET) outcomes has been confirmed by several retrospective and prospective studies . Cochrane review of prospective randomised trials of laparoscopic salpingectomy confirmed the beneficial effect of laparoscopic salpingectomy on IVF-ET outcomes in patients with hydrosalpinges. Surgery is not usually safe especially in patients with extensive adhesions, morbid obesity or previous multiple laparotomies. Furthermore, many infertile couples refuse to undergo bilateral salpingectomy or proximal tubal occlusion because these procedures remove any hope of spontaneous pregnancy. Other less invasive options for patients with hydrosalpinges as ultrasound-guided aspiration of hydrosalpingeal fluid, antibiotics (alone or combined with aspiration) and hysteroscopic occlusion of fallopian tube were studied in order to find an alternative to salpingectomy . Although these methods are simple and getting popular, current data are inadequate to recommend these treatment options instead of salpingectomy because most of the supporting evidences for these methods come from small retrospective studies. A recent randomized controlled trial revealed that the aspiration of hydrosalpingeal fluid at the time of oocyte retrieval was associated with improved implantation rate and pregnancy rates. The aim of this randomized controlled trial is to compare the efficacy of ultrasound guided aspiration of hydrosalpingeal fluid with salpingectomy in the management patients with ultrasound visible hydrosalpinges undergoing IVF-ET
Interventions
PROCEDURENeedle aspiration of hydrosalpinx
Under deep sedation, the retrieval of oocytes is done and then an aspiration needle is inserted into the hydrosalpinx under ultrasonographic guidance and suction is applied to aspirate the hydrosalpingeal fluid completely . If there are bilateral hydrosalpinges, the process is repeated on the opposite side.
PROCEDURESalpingectomy
laparoscopic surgical removal of affected tube is done with bipolar electrocoagulation for hemostasis. The mesosalpinx is coagulated as close a possible to the fallopian tube to avoid any compromise in the ovarian blood supply . In cases with marked adhesion, proximal ligation and a distal fenestration is done .
Sponsors
Aljazeera Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 37 Years
Healthy volunteers
No
Inclusion criteria
* Patients with unilateral or bilateral hydrosalpinges visible by ultrasound * Age between 18 - 37 years * Period of infertility \> 1 year * Body mass index between 19-29 * Normal basal luteinizing hormone (LH), follicle stimulating hormone (FSH) and prolactin concentrations. * Normal recent semen analysis (according to World Health Organization criteria).
Exclusion criteria
* Uterine fibroid requiring surgical removal. * Endometriosis. * Male factor of infertility requiring ICSI, Previous IVF cycles. * History of recurrent miscarriage. * Endocrinologic disorders. * Presence of systemic disease contraindicating pregnancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Number of Participants Who Achieved Clinical Pregnancy in a Transfer Cycle | 5 weeks after embryo transfer |
Secondary
| Measure | Time frame |
|---|---|
| The Number of Participants Who Achieved Ongoing Pregnancy in a Transfer Cycle . | 18 weeks after embryo transfer |
Countries
Egypt
Outcome results
None listed