Tubal Flushing Using Water Soluble Media for Unexplained Infertility

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

Study Overview

• Status: Unknown
• Conditions: Infertility
• Intervention / Treatment: Procedure: Tubal flushing by Urografin®; Drug: Diclofenac

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 Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Phase 3

Contacts and Locations

Study Locations

• Egypt
  • BeniSuef, Egypt
    • Recruiting
    • BeniSuef University hospitals
  • Cairo, Egypt
    • Recruiting
    • Cairo University Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Allergy to Iodine
• Metformin therapy
• Tubal block

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Tubal flushing with Urografin®; Women will have HSG using water soluble media	Procedure: Tubal flushing by Urografin®; Women will have tubal flushing through HSG using water soluble media (Urographin ®); Drug: Diclofenac; Women will receive oral diclofenac 50 mg (voltaren ®) 1 hour before hysterosalpingography
No Intervention: Control group; Women will not receive any intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pregnancy	Pregnancy will be defined as the presence of an intrauterine sac by vaginal ultrasound	Monthly, up to 12 months

Collaborators and Investigators

• Sponsor: Cairo University

Publications and helpful links

General Publications

• Wang R, Watson A, Johnson N, Cheung K, Fitzgerald C, Mol BWJ, Mohiyiddeen L. Tubal flushing for subfertility. Cochrane Database Syst Rev. 2020 Oct 15;10(10):CD003718. doi: 10.1002/14651858.CD003718.pub5.
• Steiner AZ, Meyer WR, Clark RL, Hartmann KE. Oil-soluble contrast during hysterosalpingography in women with proven tubal patency. Obstet Gynecol. 2003 Jan;101(1):109-13. doi: 10.1016/s0029-7844(02)02390-6.
• Spring DB, Barkan HE, Pruyn SC. Potential therapeutic effects of contrast materials in hysterosalpingography: a prospective randomized clinical trial. Kaiser Permanente Infertility Work Group. Radiology. 2000 Jan;214(1):53-7. doi: 10.1148/radiology.214.1.r00ja2353.
• Luttjeboer F, Harada T, Hughes E, Johnson N, Lilford R, Mol BW. Tubal flushing for subfertility. Cochrane Database Syst Rev. 2007 Jul 18;(3):CD003718. doi: 10.1002/14651858.CD003718.pub3.

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Anticipated): December 1, 2017
• Study Completion (Anticipated): December 1, 2017

Study Registration Dates

• First Submitted: April 24, 2015
• First Submitted That Met QC Criteria: May 4, 2015
• First Posted (Estimate): May 5, 2015

Study Record Updates

• Last Update Posted (Estimate): January 23, 2017
• Last Update Submitted That Met QC Criteria: January 20, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Manifestations; Infertility; Flushing; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Diclofenac
• Other Study ID Numbers: sub 9