- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00566956
Ultrasound-guided Hydrosalpinx Aspiration During Egg Collection
Ultrasound-guided Hydrosalpinx Aspiration During Egg Collection Improves Pregnancy Outcome in In-vitro Fertilization: a Randomised Controlled Trial
· 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?
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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-
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Birmingham, United Kingdom, B15 2TG
- Assisted Conception Unit, Birmingham Women's Hospital, Birmingham University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
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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
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No Intervention: 2
Patients assigned to group 2 will not have the hydrosalpinx aspirated
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
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2-4 weeks
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Secondary outcome measures were implantation rate, first trimester miscarriages (any pregnancy loss before 12 weeks gestation) and pelvic infection.
Time Frame: 2-4 weeks
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2-4 weeks
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Collaborators and Investigators
Investigators
- Principal Investigator: Nahed Hammadieh, MD,MRCOG, Assisted Conception Unit
Publications and helpful links
General Publications
- Strandell A, Lindhard A, Waldenstrom U, Thorburn J, Janson PO, Hamberger L. Hydrosalpinx and IVF outcome: a prospective, randomized multicentre trial in Scandinavia on salpingectomy prior to IVF. Hum Reprod. 1999 Nov;14(11):2762-9. doi: 10.1093/humrep/14.11.2762.
- 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.
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0288
- CC/APM/DD/C2/05
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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