Clinical trial NCT02008240: Salpingectomy Versus Aspiration of Hydrosalpingeal Fluid Prior to IVF-ET
Official title: Salpingectomy Versus Aspiration of Hydrosalpingeal Fluid Prior to IVF-ET.A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Infertility
Keywords: Infertility
Hydrosalpinx
IVF-ET
Salpingectomy
Lead sponsor: Aljazeera Hospital
Sponsor class: OTHER
First posted: 2013-12-11
Enrollment: 160
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 37
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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.

Primary outcomes:
measure: The Number of Participants Who Achieved Clinical Pregnancy in a Transfer Cycle
timeFrame: 5 weeks after embryo transfer
Secondary outcomes:
measure: The Number of Participants Who Achieved Ongoing Pregnancy in a Transfer Cycle .
timeFrame: 18 weeks after embryo transfer
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Aljazeera (Al Gazeera) hospital
Study officials:
affiliation: Assistant professor of Obstetrics and Gynecology , Faculty of medicine ,Cairo university , and scientific director of assisted conception unit, Aljazeera (Al Gazeera) hospital.
name: Usama M. Fouda, M.D, PhD
role: STUDY_CHAIR
affiliation: Assistant professor of Obstetrics and Gynecology , Faculty of medicine ,Cairo university, and clinical director of assisted conception unit, Aljazeera (Al Gazeera) hospital
name: Ahmed M. Sayed, M.D, PhD
role: STUDY_DIRECTOR
References:
citation: Fouda UM, Sayed AM. Effect of ultrasound-guided aspiration of hydrosalpingeal fluid during oocyte retrieval on the outcomes of in vitro fertilisation-embryo transfer: a randomised controlled trial (NCT01040351). Gynecol Endocrinol. 2011 Aug;27(8):562-7. doi: 10.3109/09513590.2010.507290. Epub 2010 Jul 30.
citation: Strandell A, Lindhard A, Waldenstrom U, Thorburn J, Janson PO, Hamberger L. Hydrosalpinx and IVF outcome: a prospective, randomized multicentre trial in Scandinavia on salpingectomy prior to IVF. Hum Reprod. 1999 Nov;14(11):2762-9. doi: 10.1093/humrep/14.11.2762.
citation: Fouda UM, Sayed AM, Abdelmoty HI, Elsetohy KA. Ultrasound guided aspiration of hydrosalpinx fluid versus salpingectomy in the management of patients with ultrasound visible hydrosalpinx undergoing IVF-ET: a randomized controlled trial. BMC Womens Health. 2015;15:21. doi: 10.1186/s12905-015-0177-2. Epub 2015 Feb 27.