NCT00566956

Brief Summary

· 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?

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Oct 1999

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 1999

Completed
4.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2004

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

November 30, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 4, 2007

Completed
Last Updated

July 21, 2015

Status Verified

November 1, 2007

First QC Date

November 30, 2007

Last Update Submit

July 20, 2015

Conditions

Infertility

Keywords

Hydrosalpinx/IVF/Reproductive outcome.Hydrosalpinx

Outcome Measures

Primary Outcomes (1)

  • 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.

    2-4 weeks

Secondary Outcomes (1)

  • Secondary outcome measures were implantation rate, first trimester miscarriages (any pregnancy loss before 12 weeks gestation) and pelvic infection.

    2-4 weeks

Study Arms (2)

1

EXPERIMENTAL

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

2

NO INTERVENTION

Patients assigned to group 2 will not have the hydrosalpinx aspirated

Interventions

Hydrosalpinx needle aspiration to arm 1PROCEDURE

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

1

Eligibility Criteria

Age20 Years - 39 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • patients not giving written informed consent;
  • patients cancelled for poor ovarian response;
  • ultrasonically diagnosed hydrosalpinx and identifiable for the first time at egg-collection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assisted Conception Unit, Birmingham Women's Hospital, Birmingham University

Birmingham, B15 2TG, United Kingdom

Location

Related Publications (2)

  • 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.

    PMID: 10548619RESULT

  • 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.

    PMID: 18343810DERIVED

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Nahed Hammadieh, MD,MRCOG

    Assisted Conception Unit

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

November 30, 2007

First Posted

December 4, 2007

Study Start

October 1, 1999

Study Completion

June 1, 2004

Last Updated

July 21, 2015

Record last verified: 2007-11

Locations

GB(1)