Tubal Flushing Using Water Soluble Media for Unexplained Infertility

Infertility Clinical Trial

Official title:

Tubal Flushing Using Water Soluble Media for Unexplained Infertility: A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02433418
• Other study ID #: sub 9
• Status: Recruiting
• Phase: Phase 3
• First received: April 24, 2015
• Last updated: January 20, 2017
• Start date: May 2015
• Est. completion date: December 2017

Study information

• Verified date: January 2017
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

Inclusion Criteria:

• infertility for one year

• Normal semen analysis

• Normal ovulation

Exclusion Criteria:

• Allergy to Iodine

• Metformin therapy

• Tubal block

Related Conditions & MeSH terms

• Flushing
• Infertility

Intervention

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

Locations

Country	Name	City	State
Egypt	BeniSuef University hospitals	BeniSuef
Egypt	Cairo University Hospitals	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

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. Review. Update in: Cochrane Database Syst Rev. 2015;5:CD003718. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pregnancy	Pregnancy will be defined as the presence of an intrauterine sac by vaginal ultrasound	Monthly, up to 12 months