Ultrasound-guided Hydrosalpinx Aspiration During Egg Collection

NCT ID: NCT00566956

Last Updated: 2015-07-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1999-10-31
• Study Completion Date: 2004-06-30

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?

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.

Conditions

Infertility

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Hydrosalpinx needle aspiration to arm 1

Intervention Type: PROCEDURE

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

2

Patients assigned to group 2 will not have the hydrosalpinx aspirated

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 39 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Birmingham Women's NHS Foundation Trust

OTHER_GOV

Sponsor Role: lead

Responsible Party

Assisted Conception Unit

Principal Investigators

Nahed Hammadieh, MD,MRCOG

Role: PRINCIPAL_INVESTIGATOR

Assisted Conception Unit

Locations

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

Birmingham, , United Kingdom

Countries

United Kingdom

References

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.

Reference Type: RESULT

PMID: 10548619 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 18343810 (View on PubMed)

Other Identifiers

CC/APM/DD/C2/05

Identifier Type: -

Identifier Source: secondary_id

0288

Identifier Type: -

Identifier Source: org_study_id