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NCT Number: NCT01040351

Ultrasound Guided Aspiration of Hydrosalpingeal Fluid and IVF-ET Outcomes

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 .

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Key information

Conditions

Infertility Genital Diseases Urogenital Diseases

Age range

18 year–37 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Ahmed Elgazzar hospital , Assisted conception unit

Giza, 35 Eleshreen Saint King Faisal., 12111, Egypt

About this study

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 .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ultrasound guided aspiration of hydrosalpingeal fluid

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.

Other names: ultrasound guided Hydrosalpinx needle aspiration

Primary outcomes

  1. The Number of Participants Who Achieved Clinical Pregnancy in a Transfer Cycle

    Time frame: 5 weeks after embryo transfer

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

    )in a transfer cycle

Secondary outcomes

  1. The Number of Participants Who Achieved Ongoing Pregnancy in a Transfer Cycle .

    Time frame: 18 weeks after embryo transfer

    The number of participants who Achieved Ongoing pregnancy (pregnancy for more than 18 weeks after embryo transfer) in a transfer cycle .

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Collaborators

  • Ahmed Elgazzar Hospital

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2010
Study completion
2010
First posted
Dec 29, 2009
Registry last updated
Aug 29, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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