Ultrasound Guided Aspiration of Hydrosalpingeal Fluid and IVF-ET Outcomes

NCT ID: NCT01040351

Last Updated: 2011-08-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-10-31
• Study Completion Date: 2010-05-31

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 .

Conditions

Infertility

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1: Hydrosalpinx needle aspiration

After the retrieval of oocytes an aspiration needle is inserted into the hydrosalpinx under ultrasonographic guidance and suction is applied to aspirate the hydrosalpingeal fluid completely .

Group Type: EXPERIMENTAL

ultrasound guided aspiration of hydrosalpingeal fluid

Intervention Type: PROCEDURE

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.

2. no aspiration

IVF-ET is done without prior aspiration of hydrosalpingeal fluid

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: PROCEDURE

Other Intervention Names

ultrasound guided Hydrosalpinx needle aspiration

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 37 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Ahmed Elgazzar Hospital

OTHER

Sponsor Role: collaborator

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Cairo university.

Principal Investigators

Usama M Fouda, M.D, PhD

Role: STUDY_CHAIR

Lecturer of obstetrics and Gynecology , Faculty of medicine ,Cairo university.

Ahmed M sayed, MD,PhD

Role: STUDY_DIRECTOR

Assistant professor of obstetrics and Gynecology , Faculty of medicine ,Cairo university.

Locations

Ahmed Elgazzar hospital , Assisted conception unit

Giza, 35 Eleshreen Saint King Faisal., Egypt

Countries

Egypt

References

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.

Reference Type: BACKGROUND

PMID: 18343810 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 20672903 (View on PubMed)

Other Identifiers

hydrosalpinx1

Identifier Type: -

Identifier Source: org_study_id