Tubal Flushing Using Water Soluble Media for Unexplained Infertility
NCT ID: NCT02433418
Last Updated: 2017-01-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
300 participants
INTERVENTIONAL
2015-05-31
2017-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Tubal flushing with Urografin®
Women will have HSG using water soluble media
Tubal flushing by Urografin®
Women will have tubal flushing through HSG using water soluble media (Urographin ®)
Diclofenac
Women will receive oral diclofenac 50 mg (voltaren ®) 1 hour before hysterosalpingography
Control group
Women will not receive any intervention
No interventions assigned to this group
Interventions
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Tubal flushing by Urografin®
Women will have tubal flushing through HSG using water soluble media (Urographin ®)
Diclofenac
Women will receive oral diclofenac 50 mg (voltaren ®) 1 hour before hysterosalpingography
Eligibility Criteria
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Inclusion Criteria
* Normal semen analysis
* Normal ovulation
Exclusion Criteria
* Metformin therapy
* Tubal block
20 Years
40 Years
FEMALE
No
Sponsors
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Cairo University
OTHER
Responsible Party
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AbdelGany Hassan
Lecturer of Gynecology and Obstetrics
Locations
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BeniSuef University hospitals
BeniSuef, , Egypt
Cairo University Hospitals
Cairo, , Egypt
Countries
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Facility Contacts
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References
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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.
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.
Other Identifiers
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sub 9
Identifier Type: -
Identifier Source: org_study_id
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