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H2Olie

 

Oil-bases contrast versus water-based contrast media in the diagnosis of tubal patency at hysterosalphingography

 

Go to the H2Olie website.

 

Background

In the evaluation of female subfertility, hysterosalpingography (HSG) is an important examination because of its diagnostic value. The procedure delineates the uterine cavity contours and the rugation and the patency of the fallopian tubes. Since the introduction of HSG as a diagnostic test, various contrast media have been used, from water-soluble to oil-soluble, ionic to nonionic, and high osmolarity to low osmolarity.

A possible therapeutic effect of diagnostic tubal patency testing has been debated in the literature for more than 50 years.

There are some small studies that show that flushing with Oil-soluble contrast medium (OSCM) has a significant higher odds ratio of live birth compared to flushing with Water-soluble contrast medium (WSCM). But other small studies showed no significant different in odds ratio of pregnancy or live births after flushing during HSG examination with OSCM or WSCM.


Objective
The purpose of this study is to determine whether at HSG the use of oil-based contrast media results in higher ongoing pregnancy and live birth rates compared to the use of water-based contrast media.

Study design
A randomized controlled trail

 

Setting

A multicenter study

Study population
Women undergoing a hysterosalpingography as part of the fertility work-up. Age between 18-39 years. Indication for tubal patency testing according to the Dutch NVOG guidelines

Intervention
Flushing with oil-based contrast versus flushing with water-based contrast medium.

 

Outcome measures
Primary outcome: ongoing pregnancy rates

Secondary outcomes: live birth rates, miscarriages, ectopic pregnancies, pain score.

 

Power/data analysis
The analysis will be by intention to treat.  A total of 1080 patients will be entered in order to prove or refuse a difference of 7% in ongoing pregnancy rate over a control rate of 18% with a power of 80% and an alpha of 0,05.

 

Nature and extend of the burden and risk associated with participation, benefit and group relatedness

As we compare strategies that are already applied in current practice, no additional risks or burdens are expected from the study.

Project leaders

drs. K. Dreyer, MD/researcher, VU Medical Center

dr. P.G.A. Hompes, gynecologist, VU Medical Center

Prof. dr. B.W. Mol, gynecologist, Academic Medical Center
 

Contact

Drs. K. Dreyer, MD/researcher

VU Medical Center

Tel: 020-4445277 / 06-42312075

Email: h2olie@studies-obsgyn.nl