Route B: Single site laparoscopy for Female Infertility

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
The University of Texas Health Science Center at Houston, Houston, TX
Female Infertility+2 More
V-Notes surgery - Device
Eligibility
18 - 65
Female
What conditions do you have?
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Study Summary

The purpose of this study is to compare and capture key elements of the patient experience, quality of recovery, preferences and satisfaction after laparoscopic salpingectomy done via 3 different routes.

Eligible Conditions

  • Female Infertility

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Female Infertility

Study Objectives

1 Primary · 5 Secondary · Reporting Duration: 3 months post surgery

24 hours after surgery
Quality of recovery after surgery as assessed by the Quality of Recovery (QOR-40 )questionnaire
3 months post surgery
Cosmesis as assessed by the Body Image Questionnaire
Pain as assessed by the Dynamic Visual Analog Scale (VAS)
Pain as assessed by the Resting Visual Analog Scale (VAS)
Patient satisfaction as assessed by the satisfaction scale
Month 3
Change in sexual function as assessed by the Short version of the Female Sexual Function Index (FSFI)

Trial Safety

Safety Progress

1 of 3

Other trials for Female Infertility

Trial Design

3 Treatment Groups

Route A: Traditional laparoscopy
1 of 3
Route B: Single site laparoscopy
1 of 3
Route C:V-Notes surgery"
1 of 3
Active Control
Experimental Treatment

150 Total Participants · 3 Treatment Groups

Primary Treatment: Route B: Single site laparoscopy · No Placebo Group · N/A

Route B: Single site laparoscopy
Device
Experimental Group · 1 Intervention: Single site laparoscopy · Intervention Types: Device
Route C:V-Notes surgery"
Device
Experimental Group · 1 Intervention: V-Notes surgery · Intervention Types: Device
Route A: Traditional laparoscopy
Device
ActiveComparator Group · 1 Intervention: Traditional laparoscopy · Intervention Types: Device

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 3 months post surgery

Trial Background

Prof. Randa Jalloul, Associate Professor
Principal Investigator
The University of Texas Health Science Center, Houston
Closest Location: The University of Texas Health Science Center at Houston · Houston, TX
Photo of Houston  1Photo of Houston  2Photo of Houston  3
2008First Recorded Clinical Trial
1 TrialsResearching Female Infertility
190 CompletedClinical Trials

Eligibility Criteria

Age 18 - 65 · Female Participants · 3 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are scheduled to undergo an elective sterilization surgery regardless of parity.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.