Eur. J. Obstet. Gynecol. Reprod. Biol., 28 (1988) 65-68 Elsevier

65

I30 00608

Oil or aqueous contrast media for hysterosalpingography: a prospective,

randomized, clinical study

A.D. de Boer ‘, H.M. Vemer ‘, W.N.P. Willemsen ’ and F.B.M. Sanders * ’ Department of Obstetrics and Gynecology

and 2 Department of Radiology, St. Radboud University Hospital, Nijmegen, The Netherlands

Accepted for publication 30 December 1987

In this prospective randomized clinical study the pregnancy rate and the quality of the images obtained by hysterosalpingography (HSG) in 175 women with fertility problems have been compared using an oil-soluble contrast medium and an aqueous contrast medium. After the HSG there was a follow-up period of 6 months. No statistically significant difference in pregnancy rate was found. With both contrast media good images were obtained. The oil-soluble contrast medium gave a more sharply outlined uterine cavity, the aqueous contrast medium showed more tubal details. Furthermore, the control picture with the aqueous contrast medium can be prepared after ten minutes. We conclude that the use of an aqueous contrast medium for routine HSG is preferable.

Hysterosalpingography; Contrast medium; Pregnancy rate; Quality of image

Introduction

Hysterosalpingographies (HSGs) are often performed in the fertility work-up routine on females. Besides the diagnostic value, an HSG is said to have a therapeutic effect as well, meaning an increased pregnancy rate afterwards. The alleged high pregnancy rate is especially ascribed to oil soluble contrast media [2,3,5-S]. However, the quality of the radiographic image is said to be superior with an aqueous contrast medium [5,7,8]. The choice of an oil-soluble contrast medium versus an aqueous contrast medium is therefore still debatable.

Correspondence: W.N.P. Willemsen, MD, Department of Obstetrics and Gynecology, St. Radboud University Hospital, P.O. Box 9101, 6500 HB Nijmegen, The Netherlands.

0028-2243/88/$03.50 0 1988 Elsevier Science Publishers B.V. (Biomedical Division)

In this prospective, randomized, clinical study the pregnancy rate after HSGs and the quality of the radiological image are compared for oil-soluble and aqueous

contrast media.

Materials and methods

One hundred and seventy-five patients were selected according to the following criteria: (i) primary or secondary infertility of at least six months duration; (ii) a biphasic basal body temperature chart with a luteal phase of at least 12 days; (iii) a positive post-coital test (Sims-Htihner test) and/or a positive sperm penetration test (Kremer test).

Exclusion criteria were: (i) fertility surgery in the past; (ii) two occluded tubes on the HSG.

The selected women, aged between 19 and 44 years (mean 29 years) and a mean infertility duration of 37.0 months (SD = 26.2, modus between 1 and 2 years, median 22 months). They were randomly divided into two groups. In one group the

HSG was performed with the aqueous contrast medium Iopamidol. Iopamidol (Bracco, Italy) is a synthetic non-ionic contrast medium with a low osmolarity; viscosity, 9 mPa; density, 1.33 kg/l; iodine concentration, 30% w/v, measured at 37.0” C. In the other group the oil-soluble contrast medium Ethiodol was used. Ethiodol (Guerbet, France) is a mixture of derivatives of several fatty acids obtained from poppy seed oil; viscosity, 25 mPa; density, 1.28 kg/l; iodine concentration 48% w/v, measured at 37.O“C.

The HSG was performed between the 6th and the 13th day of the menstrual cycle. A standard technique was applied. The patient was placed in lithotomy position, a bivalve speculum was used, the portio was hooked on by a tenaculum, the cervix was swabbed with bethadine, a canula was inserted into the ostium and 10 ml dye were injected into the uterine cavity under fluoroscopic control. No

complications were seen. Between February 1985 and October 1986 all participating women were fol-

lowed-up after the HSG for six months. During these 6 months coitus took place regularly and only hormonal therapy was used. Any pregnancy occurring during this period was recorded. The HSGs of the first 111 women were examined and scored by a single radiologist for the following items: (i) outlines of the uterine cavity; (ii) lining of the various parts of the tubes; (iii) overflow into the peritoneal cavity; (iv) dye dispersion and absorption in the pelvis. The different items were assessed as good, fair or insufficient, and sharp or not sharp. For statistical evaluation the Chi

square test was used.

Results

Both groups were comparable concerning age, primary or secondary infertility and duration of infertility. Pregnancy rates in the two groups are shown in Table I. No statistically significant difference between the pregnancy rates was found.

The visualization of the uterine cavity is given in Table II. The outline of the uterine cavity was statistically significantly sharper with the oil-soluble contrast medium.

TABLE I

Pregnancy rates after HSG

n Pregnant (a) Non-pregnant(%)

Oil-soluble contrast medium

Aqueous contrast medium

x2=1.44 P < 0.1

87 30 (34) 57 (66)

88 23 (26) 65 (74)

TABLE II

The visualization of the uterine cavity

n Sharp (‘Q Not sharp (W) Not applicable (%)

Oil-soluble contrast medium

Aqueous contrast medium xs = 12.1 P < 0.01

53 49 (92) 0 (0) 4 (8)

58 43 (74) 12 (21) 3 (5)

TABLE III

The visualization of the tubal folds in the ampullary part

n Tubal folds visible (W)

Oil-soluble contrast medium

Aqueous contrast medium

x2 = 68.8 P < 0.01

2x53 12 (11)

2x58 77 (66)

The visualization of the tubal folds in the ampullary part of the tubes is shown in Table III. The ampullary folds appeared to be visible more frequently with the aqueous contrast medium. This difference was also statistically significant. Regard- ing the presence of contrast medium in the pelvis seen on the control film, the

aqueous contrast medium showed a dispersion after 10 min and was statistically significantly resorbed more frequently, while the oil-soluble contrast medium ap- peared to have dispersed through the pelvis only after at least 2 hours and was

statistically significantly more frequently still present in the pelvis.

Discussion

Explanations for the assumed increased pregnancy rate following HSG [2,4,8] given in the literature are not based on prospective randomized studies. It is not clear why this high pregnancy rate would be especially an effect of oil-soluble contrast medium. Similarly to the results of the prospective randomized study of Alper et al. [l], we have found no statistically significant difference in pregnancy rates either. Although an oil-soluble contrast medium is supposed to provide a sharper and more contrasting image [l,S,S], during our studies this only held true for the uterine cavity. This may be due to the higher iodine concentration and the

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separation of the oily contrast phase and the watery mucous phase. An aqueous contrast medium is likely to penetrate excretory ducts and to blend with secretion products, giving rise to an unclear image. The lower iodine concentration causes a less dense image of the uterine cavity. The same physicochemical properties enable us to obtain a more detailed image of the mucosa [1,8], as evidenced by a more frequent visualization of the tubal folds. An oil-soluble contrast medium can persist for months to years in the peritoneal cavity and in occluded tubes, possibly leading to complications such as granuloma formation and foreign-body reactions [1,2,5,8]. The control film after HSG with an oil-soluble contrast medium must be made several hours after the procedure.

An aqueous contrast medium disperses and dilutes almost immediately in the peritoneal cavity and is completely resorbed within 15 min, so that the control picture can be made within 15 min. For the comfort of the patients and for clinical convenience this is preferable. A well-known complication of HSG is the venous or lymphatic intravasation by contrast medium (incidence O-6%). With an oil-soluble contrast medium this can lead to oil emboli, rarely resulting in serious cardiovascu- lar problems [1,2,8]. We concluded that for HSG the use of aqueous contrast medium is preferable. The use of an oil-soluble contrast medium can be considered when malformations of the uterine cavity are suspected.

References

1 Alper MM, Gamer PR, Spence JEH, Quarrington AM. Pregnancy rates after hysterosalpingography with oil- and water-soluble contrast media. Obstet Gynecol 1986;66:6-9.

2 Cooper RA, Jabamoni R, Pieters CT. Fertility rate after hysterosalpingogram with Sinografine. Am J

Radio1 1983;141:105-106. 3 De Chemey AH, Kort H, Barney JB, De Vore GR. Increased pregnancy rate with oil soluble

hysterosalpingography dye. Fertil Steril 1980;33:407-410. 4 Kotwatsch AW, Tscheme G, Urdl W. Schwangerschaften nach tubendiagnostische Massnahmen.

Geburtsh Frauenheilk 1983;43:302-305.

5 Mackey RA, Glass RH, Olson LE, Vaidye R. Pregnancy following hysterosalpingography with oil and water soluble dye. Fertil Steril 1971;22:504-507.

6 Schiitte HE. Comparative study: Endografin (Diatrizoate), Vasurixpolyvidone (acetrizoate), Dimer X (Iocamate) and Hexabrix (Ioxaglate) in hysterosalpingography. Diagnostic Imaging 1982;51:227-283.

7 Schwabe MG, Shapiro SS, Haning RV. Hysterosalpingogram with oil contrast medium enhances fertility in patients with infertility of unknown etiology. Fertil Steril 1983;40:604-606.

8 Soules MR, Spadoni LR. Oil versus aqueous media for hysterosalpingography, a continuing debate based on many opinions and a few facts. Fertil Steril 1982;38:1-11.