Tubal Flushing Using Water Soluble Media for Unexplained Infertility

Phase 3

• Conditions: Infertility
• Interventions: Procedure: Tubal flushing by Urografin®; Drug: Diclofenac

• Registration Number: NCT02433418
• Lead Sponsor: Cairo University

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study First Submitted: 2015-04-24
• Study Start: 2015-05
• Study First Submitted QC: 2015-05-04
• Study First Posted: 2015-05-05
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-20
• Last Update Posted: 2017-01-23
• Primary Completion: 2017-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 300

Inclusion Criteria

• infertility for one year
• Normal semen analysis
• Normal ovulation

Exclusion Criteria

• Allergy to Iodine
• Metformin therapy
• Tubal block

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tubal flushing with Urografin®	Tubal flushing by Urografin®	Women will have HSG using water soluble media
Tubal flushing with Urografin®	Diclofenac	Women will have HSG using water soluble media

Primary Outcome Measures

Name	Time	Method
Pregnancy	Monthly, up to 12 months	Pregnancy will be defined as the presence of an intrauterine sac by vaginal ultrasound

Trial Locations

Locations (2)

BeniSuef University hospitals; 🇪🇬 BeniSuef, Egypt

Cairo University Hospitals; 🇪🇬 Cairo, Egypt