Ultrasound-guided Hydrosalpinx Aspiration During Egg Collection

Birmingham Women's NHS Foundation Trust

Status and phase: Terminated; Phase 2

Conditions: Infertility

Treatments: Procedure: Hydrosalpinx needle aspiration to arm 1

Study type: Interventional

Funder types: Other

Identifiers

NCT00566956

CC/APM/DD/C2/05

0288

Details and patient eligibility

About

· 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?

Full 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.

Enrollment: 66 patients

Sex: Female

Ages: 20 to 39 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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66 participants in 2 patient groups

1

Experimental group

Description:

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.

Treatment:

Procedure: Hydrosalpinx needle aspiration to arm 1

2

No Intervention group

Description:

Patients assigned to group 2 will not have the hydrosalpinx aspirated