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Ultrasound-Guided Hydrosalpinx Aspiration During Egg Collection

This study has been terminated.
(The study was terminated because it is very difficult to recruit more patients.)
Sponsor:
Information provided by:
Birmingham Women's NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT00566956
First received: November 30, 2007
Last updated: NA
Last verified: November 2007
History: No changes posted
  Purpose

· What we know: Hydrosalpinx and IVF About 40% of patients undergoing IVF have tubal disease and in 25%-30% of tubal disease patients there is fluid collection within the tube; hydrosalpinx. The amount of fluid in the hydrosalpinx is known to increase with ovarian stimulation (as in IVF) and often empties into the uterine cavity. Fluid from hydrosalpinges has been found to be detrimental to the growth and development of mouse embryos in vitro, and associated with reduced levels of endometrial integrins in vivo. This could be the explanation of the reduced pregnancy rates after IVF in patients with tubal disease and hydrosalpinx compared with those with tubal disease but no hydrosalpinx. This effect was evidence in both fresh and frozen embryo transfer cycles. Also there was a significant increase in miscarriage in association with hydrosalpinx.

The study aims to answer the question: does ultrasound-guided aspiration of ultrasound diagnosed hydrosalpinx at the time of egg collection improve the pregnancy rate in IVF?


Condition Intervention Phase
Infertility
 Procedure: Hydrosalpinx needle aspiration to arm 1
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Ultrasound-Guided Hydrosalpinx Aspiration During Egg Collection Improves Pregnancy Outcome in in-Vitro Fertilization: a Randomised Controlled Trial

Resource links provided by NLM:

MedlinePlus related topics: Infertility
U.S. FDA Resources

Further study details as provided by Birmingham Women's NHS Foundation Trust:

Primary Outcome Measures:
  • The primary outcome measures were biochemical (urinary hCG test performed 14 days after embryo transfer) and clinical (presence of gestational sac by transvaginal ultrasound scan) pregnancy rates per randomised women. [ Time Frame: 2-4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Secondary outcome measures were implantation rate, first trimester miscarriages (any pregnancy loss before 12 weeks gestation) and pelvic infection. [ Time Frame: 2-4 weeks ] [ Designated as safety issue: No ]

Enrollment: 66
Study Start Date: October 1999
Study Completion Date: June 2004
Arms Assigned Interventions
Experimental: 1
For those assigned to Group 1, the hydrosalpinx will be aspirated after all the eggs have been collected, under GA. Under ultrasound-guidance, the aspiration (egg collection) needle will be inserted into the hydrosalpinx and suction applied until no more fluid is obtained. If there are bilateral hydrosalpinges, the process is repeated on the opposite side.
 Procedure: Hydrosalpinx needle aspiration to arm 1
For those assigned to Group I, the hydrosalpinx will be aspirated after all the eggs have been collected, under GA. Under ultrasound-guidance, the aspiration (egg collection) needle will be inserted into the hydrosalpinx and suction applied until no more fluid is obtained. If there are bilateral hydrosalpinges, the process is repeated on the opposite side. The hydrosalpinx fluid is discarded
No Intervention: 2
Patients assigned to group 2 will not have the hydrosalpinx aspirated
 Procedure: Hydrosalpinx needle aspiration to arm 1
For those assigned to Group I, the hydrosalpinx will be aspirated after all the eggs have been collected, under GA. Under ultrasound-guidance, the aspiration (egg collection) needle will be inserted into the hydrosalpinx and suction applied until no more fluid is obtained. If there are bilateral hydrosalpinges, the process is repeated on the opposite side. The hydrosalpinx fluid is discarded

Detailed Description:

· What we do not know: Treatment of hydrosalpinx and IVF Several studies in the literature have suggested that the treatment of hydrosalpinx pre-IVF would improve the pregnancy rate to a level similar to tubal disease patients without hydrosalpinx. The treatment modalities explored were salpingectomy, salpingostomy, tubal occlusion and ultrasound-guided aspiration either one month before or at the time of egg collection. All studies reported to date have been retrospective and with poor control design. A prospective randomised controlled trial is needed. All modalities have been associated with a similar improvement in pregnancy rate, but the least invasive modality is ultrasound-guided aspiration at the time of oocyte collection. We propose to conduct a prospective randomised controlled trial to evaluate the effect of ultrasound-guided aspiration (versus no aspiration) of hydrosalpinx at the time of egg collection on the pregnancy rate in IVF.

  Eligibility

Ages Eligible for Study:   20 Years to 39 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy women, ASA class 1 (normal healthy) or class 2 (with mild systemic disease);
  • undergoing IVF or ICSI and reaching the stage of egg collection;
  • with ultrasonically diagnosed hydrosalpinx and identifiable during the phase of ovarian stimulation;
  • giving written informed consent.

Exclusion Criteria:

  • patients not giving written informed consent;
  • patients cancelled for poor ovarian response;
  • ultrasonically diagnosed hydrosalpinx and identifiable for the first time at egg-collection
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00566956

Locations
United Kingdom
Assisted Conception Unit, Birmingham Women's Hospital, Birmingham University
Birmingham, United Kingdom, B15 2TG
Sponsors and Collaborators
Birmingham Women's NHS Foundation Trust
Investigators
Principal Investigator: Nahed Hammadieh, MD,MRCOG Assisted Conception Unit
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Mr M Afnan, Assisted Conception Unit
ClinicalTrials.gov Identifier: NCT00566956     History of Changes
Other Study ID Numbers: 0288, CC/APM/DD/C2/05
Study First Received: November 30, 2007
Last Updated: November 30, 2007
Health Authority: United Kingdom: National Health Service

Keywords provided by Birmingham Women's NHS Foundation Trust:
Hydrosalpinx/IVF/Reproductive outcome.
Hydrosalpinx

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

ClinicalTrials.gov processed this record on May 19, 2013