Infertility Clinical Trial
Official title:
Tubal Flushing Using Water Soluble Media for Unexplained Infertility: A Randomized Controlled Trial
300 women with unexplained infertility will be randomly divided into 2 equal groups: Group 1 will be offered tubal flushing with water soluble media through hysterosalpingography (HSG) and group 2 will receive no intervention
The potential therapeutic effect of diagnostic tubal patency testing has been debated for
over 40 years. Tubal flushing might involve water- or oil-soluble media. Current practice
usually involves water-soluble media when tubal flushing is performed at laparoscopy. A
systematic review showed a significant increase in pregnancy rates with tubal flushing using
oil-soluble contrast media when compared with no treatment. Tubal flushing with oil soluble
contrast media was associated with an increase in the odds of live birth when compared with
tubal flushing with water-soluble media. There were no trials assessing tubal flushing with
water-soluble media versus no treatment. The potential consequences of extravasations of
oil-soluble contrast media into the pelvic cavity and fallopian tubes may be associated with
anaphylaxis and lipogranuloma. It has been reported that Further randomised controlled
trials are needed to evaluate the potentially therapeutic effects of tubal flushing with
water-soluble media.
All patients attending the subfertility clinic with infertility, normal semen analysis and
evidence of ovulation will be invited to participate in the study. The nature of the study
and its expected values will be explained and only women who provide written consents will
be included in the study.
Three hundred women will be divided into 2 equal groups using computer generated random
numbers: Group 1 will have tubal flushing with HSG using water soluble media and group 2
will be the control group receiving no intervention.
Women undergoing HSG will be given 50 mg of diclofenac (Voltaren® Novartis) 1 hour before
the procedure. The HSG will be performed in the same room, on the same table and with the
same technique to maintain consistency and limit confounding variables.
The HSG procedure will performed in a lithotomy position. A sterile metal speculum was used
to visualize the uterine cervix. Antiseptic solution will be used to wash the vagina and
cervix. A single-toothed tenaculum will be placed on the anterior lip of the cervix. A metal
cannula will be gently inserted into the external cervical os, the cannula and tenaculum
will be secured together, and the speculum will be removed. Gentle traction will be placed
on the tenaculum, and 15 mL to 20 mL of water-soluble media (Sodium Amidotrizoate;
urografin®, Bayer, Germany) will be instilled slowly via the cannula to prevent pain while
the necessary images were obtained. After the procedure, the instruments will be removed and
the patient will be observed for 30 minutes.
Women will be followed up monthly for up to 1 year.
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