Ultrasound Guided Aspiration of Hydrosalpingeal Fluid and IVF-ET Outcomes

Infertility Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01040351
• Other study ID #: hydrosalpinx1
• Status: Completed
• Phase: Phase 2
• First received: December 28, 2009
• Last updated: July 29, 2011
• Start date: October 2006
• Est. completion date: May 2010

Study information

• Verified date: October 2010
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Interventional

Clinical Trial 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 .

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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: May 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 37 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infertility

Intervention

Procedure:
• ultrasound guided aspiration of hydrosalpingeal fluid
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.

Locations

Country	Name	City	State
Egypt	Ahmed Elgazzar hospital , Assisted conception unit	Giza	35 Eleshreen st. King Faisal.

Sponsors (2)

Lead Sponsor	Collaborator
Cairo University	Ahmed Elgazzar Hospital

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Number of Participants Who Achieved Clinical Pregnancy in a Transfer Cycle	The Number of Participants Who Achieved Clinical Pregnancy( presence of intrauterine gestational sac detected by transvaginal ultrasound; )in a transfer cycle	5 weeks after embryo transfer	No
Secondary	The Number of Participants Who Achieved Ongoing Pregnancy in a Transfer Cycle .	The number of participants who Achieved Ongoing pregnancy (pregnancy for more than 18 weeks after embryo transfer) in a transfer cycle .	18 weeks after embryo transfer	No