Ultrasound Guided Aspiration of Hydrosalpingeal Fluid and IVF-ET Outcomes

This study has been completed.
Sponsor:
Collaborator:
Ahmed Elgazzar Hospital
Information provided by:
Cairo University
ClinicalTrials.gov Identifier:
NCT01040351
First received: December 28, 2009
Last updated: July 29, 2011
Last verified: October 2010
  Purpose

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 .


Condition Intervention Phase
Infertility
Procedure: ultrasound guided aspiration of hydrosalpingeal fluid
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Cairo University:

Primary Outcome Measures:
  • The Number of Participants Who Achieved Clinical Pregnancy in a Transfer Cycle [ Time Frame: 5 weeks after embryo transfer ] [ Designated as safety issue: No ]

    The Number of Participants Who Achieved Clinical Pregnancy( presence of intrauterine gestational sac detected by transvaginal ultrasound

    )in a transfer cycle



Secondary Outcome Measures:
  • The Number of Participants Who Achieved Ongoing Pregnancy in a Transfer Cycle . [ Time Frame: 18 weeks after embryo transfer ] [ Designated as safety issue: No ]
    The number of participants who Achieved Ongoing pregnancy (pregnancy for more than 18 weeks after embryo transfer) in a transfer cycle .


Enrollment: 110
Study Start Date: October 2006
Study Completion Date: May 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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 .
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.
Other Name: ultrasound guided Hydrosalpinx needle aspiration
No Intervention: 2. no aspiration
IVF-ET is done without prior aspiration of hydrosalpingeal fluid

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

Ages Eligible for Study:   18 Years to 37 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01040351

Locations
Egypt
Ahmed Elgazzar hospital , Assisted conception unit
Giza, 35 Eleshreen st. King Faisal., Egypt, 12111
Sponsors and Collaborators
Cairo University
Ahmed Elgazzar Hospital
Investigators
Study Chair: Usama M Fouda, M.D, PhD Lecturer of obstetrics and Gynecology , Faculty of medicine ,Cairo university.
Study Director: Ahmed M sayed, MD,PhD Assistant professor of obstetrics and Gynecology , Faculty of medicine ,Cairo university.
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Usama Fouda , MD, PhD, Cairo university.
ClinicalTrials.gov Identifier: NCT01040351     History of Changes
Other Study ID Numbers: hydrosalpinx1
Study First Received: December 28, 2009
Results First Received: May 10, 2010
Last Updated: July 29, 2011
Health Authority: Egypt: Institutional Review Board

Keywords provided by Cairo University:
Infertility
Hydrosalpinx
IVF-ET

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on August 27, 2014