Hysteroscopic Evaluation of Fallopian Tubal Patency

NCT04077242 | Completed

• 1 other identifier: 1341/2019
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Hysteroscopy is an important tool in the evaluation of sterility. Assessing tubal patency during hysteroscopy seems highly relevant, particularly when it allows for a low cost, fast, gentle, and accurate way of gathering information that may guide clinical care. Therefore, it is important to know which technique is the best. Thus, the primary aim of this study is to evaluate the reliability of (1.) the hysteroscopic visualization of a "tubal flow" and (2.) the "Parryscope technique" as compared to the gold standard, namely laparoscopic chromopertubation. In a prospective, randomized study, the following women are enrolled: (1.) The patient is subfertile, defined as being unable to become pregnant within a year despite unprotected sexual intercourse. It is also within the standard of care to be presumed subfertile if one has tried for six months and has known risk factors that would hinder conception, including but not limited to anovulation and endometriosis. (2.) A concurrent diagnostic hysteroscopy and laparoscopy with chromopertubation are performed at the Clinical Division of Gynecological Endocrinology and Reproductive Medicine at the Medical University of Vienna. Hysteroscopic evaluation of tubal patency (either by a positive "tubal flow" or a visible flow of air bubbles in the "Parryscope technique") and the result of the laparoscopic chromopertubation (tubal patency existing or not existing) will be the primary outcome parameters. A total 60 patients are enrolled (30 patients in the "flow assessment" group, 30 patients in the "Parryscope" group) and randomization is performed as block randomization in 4 blocks.

Conditions

Infertility of Tubal Origin; Infertility, Female; Fallopian Tube Occlusion; Uterus Abnormal

Keywords

hysteroscopy; Parryscope; chromopertubation

Outcome Measures

Primary Outcomes (1)

• Fallopian tube patency using laparoscopic chromopertubation

  tubal patency as assessed by chromopertubation (information provided separately for each side)

  In the course of subsequent laparoscopy, i.e. 20-60 minutes after the diagnostic intervention

Study Arms (2)

"Parryscope"-group

ACTIVE COMPARATOR

In these patients, Fallopian tube patency is assessed using the "Parryscope" technique. A small amount of air is introduced into the iv tubing by inverting the drip chamber to create air bubbles. When air enters the uterine cavity, a single large air bubble or stream of air bubbles traversing the ostia is considered indicative of tubal patency. At least 10 seconds of intracavitary evaluation is typically performed before air bubble entry to allow pressure equilibration if a hydrosalpinx is present \[10\]. At least 30 seconds of observation per ostia is performed if patency is not observed.

Diagnostic Test: Hysteroscopic Fallopian tube assessment using the "Parryscope" technique

"Tubal flow"-group

ACTIVE COMPARATOR

In these patients, Fallopian tube patency is assessed using the "flow" technique. a positive "flow" is defined as the observation of saline directly traversing the ostia, endometrial structures floating toward the ostia, or air bubbles traversing the ostia.

Diagnostic Test: Hysteroscopic Fallopian tube assessment using the "Tubal flow" technique

Interventions

Hysteroscopic Fallopian tube assessment using the "Parryscope" technique DIAGNOSTIC_TEST

A small amount of air is introduced into the iv tubing by inverting the drip chamber to create air bubbles. When air enters the uterine cavity, a single large air bubble or stream of air bubbles traversing the ostia is considered indicative of tubal patency. At least 10 seconds of intracavitary evaluation is typically performed before air bubble entry to allow pressure equilibration if a hydrosalpinx is present \[10\]. At least 30 seconds of observation per ostia is performed if patency is not observed.

"Parryscope"-group

Hysteroscopic Fallopian tube assessment using the "Tubal flow" technique DIAGNOSTIC_TEST

a positive "flow" is defined as the observation of saline directly traversing the ostia, endometrial structures floating toward the ostia, or air bubbles traversing the ostia.

"Tubal flow"-group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• The patient is subfertile, defined as being unable to become pregnant within a year despite unprotected sexual intercourse. It is also within the standard of care to be presumed subfertile if one has tried for six months and has known risk factors that would hinder conception, including but not limited to anovulation and endometriosis.
• A concurrent diagnostic hysteroscopy and laparoscopy with chromopertubation are performed at the Clinical Division of Gynecological Endocrinology and Reproductive Medicine at the Medical University of Vienna.
• The patient has given her written informed consent after detailed information on the study by medical professionals at the Department of Obstetrics and Gynecology of the Medical University of Vienna.
• The patient is over 18 and under 45 years old.

You may not qualify if:

• The patient had a tubectomy on one or both sides.
• There is no "informed consent".
• The patients has active vaginal infection or other conditions that would preclude hysteroscopy.

Sponsors & Collaborators

• Medical University of Vienna: lead
• University of Mississippi Medical Center: collaborator

Study Sites (1)

Medical University of Vienna, Clinical Division of Gynecologic Endocrinology and Reproductive Medicine

Vienna, 1090, Austria

Location

Related Publications (13)

• Cholkeri-Singh A, Sasaki KJ. Hysteroscopy for infertile women: a review. J Minim Invasive Gynecol. 2015 Mar-Apr;22(3):353-62. doi: 10.1016/j.jmig.2014.12.163. Epub 2014 Dec 29.

  PMID: 25553895 BACKGROUND

• Godinjak Z, Idrizbegovic E. Should diagnostic hysteroscopy be a routine procedure during diagnostic laparoscopy in infertile women? Bosn J Basic Med Sci. 2008 Feb;8(1):44-7. doi: 10.17305/bjbms.2008.2996.

  PMID: 18318671 BACKGROUND

• Indraccolo U, Greco P, Scutiero G, Marrocchella S, Sorrentino F, Mastricci L, Matteo M. The role of hysteroscopy in the diagnostic work-up of infertile asymptomatic patients. Clin Exp Obstet Gynecol. 2014;41(2):124-7.

  PMID: 24779234 BACKGROUND

• Mahran A, Abdelraheim AR, Eissa A, Gadelrab M. Does laparoscopy still has a role in modern fertility practice? Int J Reprod Biomed. 2017 Dec;15(12):787-794.

  PMID: 29492476 BACKGROUND

• Zhang E, Zhang Y, Fang L, Li Q, Gu J. Combined hysterolaparoscopy for the diagnosis of female infertility: a retrospective study of 132 patients in china. Mater Sociomed. 2014 Jun;26(3):156-7. doi: 10.5455/msm.2014.26.156-157. Epub 2014 Jun 21.

  PMID: 25126006 BACKGROUND

• Parry JP, Isaacson KB. Hysteroscopy and why macroscopic uterine factors matter for fertility. Fertil Steril. 2019 Aug;112(2):203-210. doi: 10.1016/j.fertnstert.2019.06.031.

  PMID: 31352959 BACKGROUND

• Promberger R, Simek IM, Nouri K, Obermaier K, Kurz C, Ott J. Accuracy of Tubal Patency Assessment in Diagnostic Hysteroscopy Compared with Laparoscopy in Infertile Women: A Retrospective Cohort Study. J Minim Invasive Gynecol. 2018 Jul-Aug;25(5):794-799. doi: 10.1016/j.jmig.2017.11.020. Epub 2017 Dec 6.

  PMID: 29221993 BACKGROUND

• Hager M, Simek IM, Promberger R, Ott J. The Role of Diagnostic Hysteroscopy in the Evaluation of Fallopian Tube Patency: a Short Review. Geburtshilfe Frauenheilkd. 2019 May;79(5):483-486. doi: 10.1055/a-0826-1326. Epub 2019 May 21.

  PMID: 31148848 BACKGROUND

• Habibaj J, Kosova H, Bilali S, Bilali V, Qama D. Comparison between transvaginal sonography after diagnostic hysteroscopy and laparoscopic chromopertubation for the assessment of tubal patency in infertile women. J Clin Ultrasound. 2012 Feb;40(2):68-73. doi: 10.1002/jcu.20883. Epub 2011 Sep 20.

  PMID: 21935964 BACKGROUND

• Parry JP, Riche D, Aldred J, Isaacs J, Lutz E, Butler V, Shwayder J. Proximal Tubal Patency Demonstrated Through Air Infusion During Flexible Office Hysteroscopy Is Predictive of Whole Tubal Patency. J Minim Invasive Gynecol. 2017 May-Jun;24(4):646-652. doi: 10.1016/j.jmig.2017.02.010. Epub 2017 Feb 16.

  PMID: 28216455 BACKGROUND

• Torok P, Major T. Accuracy of assessment of tubal patency with selective pertubation at office hysteroscopy compared with laparoscopy in infertile women. J Minim Invasive Gynecol. 2012 Sep-Oct;19(5):627-30. doi: 10.1016/j.jmig.2012.03.016.

  PMID: 22935304 BACKGROUND

• Parry JP, Riche D, Rushing J, Linton B, Butler V, Lindheim SR. Performing the Parryscope technique gently for office tubal patency assessment. Fertil Steril. 2017 Oct;108(4):718. doi: 10.1016/j.fertnstert.2017.07.1159. Epub 2017 Aug 31.

  PMID: 28843382 BACKGROUND

• Hajian-Tilaki K. Sample size estimation in diagnostic test studies of biomedical informatics. J Biomed Inform. 2014 Apr;48:193-204. doi: 10.1016/j.jbi.2014.02.013. Epub 2014 Feb 26.

  PMID: 24582925 BACKGROUND

MeSH Terms

Conditions

Infertility, Female; Uterine Anomalies

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infertility

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc.Prof. Priv.Doz. Dr.

Study Record Dates

• First Submitted: August 24, 2019
• First Posted: September 4, 2019
• Study Start: May 31, 2019
• Primary Completion: October 25, 2019
• Study Completion: October 25, 2019
• Last Updated: December 12, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)