Clinical trial NCT01040351: Ultrasound Guided Aspiration of Hydrosalpingeal Fluid and IVF-ET Outcomes
Official title: Effect of Ultrasound Guided Aspiration of Hydrosalpingeal Fluid at the Time of Oocyte Retrieval on the Outcomes of IVF-ET, a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Infertility
Keywords: Infertility
Hydrosalpinx
IVF-ET
Lead sponsor: Cairo University
Sponsor class: OTHER
Collaborators: name: Ahmed Elgazzar Hospital
First posted: 2009-12-29
Enrollment: 110
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 study is to determine whether the ultrasound guided aspiration of hydrosalpingeal fluid at the time of oocyte retrieval can improve the outcomes of IVF-ET .

Detailed description: A Cochrane review of prospective randomized 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 and previous multiple laparotomies. Other less invasive options for patients with hydrosalpinges as ultrasound guided aspiration of hydrosalpingeal fluid, antibiotics 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. The aim of this study is to determine whether the ultrasound guided aspiration of hydrosalpingeal fluid at the time of oocyte retrieval can improve the outcomes of 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: Ahmed Elgazzar hospital , Assisted conception unit
state: 35 Eleshreen st. King Faisal.
Study officials:
affiliation: Lecturer of obstetrics and Gynecology , Faculty of medicine ,Cairo university.
name: Usama M Fouda, M.D, PhD
role: STUDY_CHAIR
affiliation: Assistant professor of obstetrics and Gynecology , Faculty of medicine ,Cairo university.
name: Ahmed M sayed, MD,PhD
role: STUDY_DIRECTOR
References:
citation: Hammadieh N, Coomarasamy A, Ola B, Papaioannou S, Afnan M, Sharif K. Ultrasound-guided hydrosalpinx aspiration during oocyte collection improves pregnancy outcome in IVF: a randomized controlled trial. Hum Reprod. 2008 May;23(5):1113-7. doi: 10.1093/humrep/den071. Epub 2008 Mar 13.
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.