Effects of Salpingectomy During Laparoscopic Hysterectomy on Ovarian Function
1 other identifier
interventional
30
1 country
1
Brief Summary
The purpose of this study is to assess the feasibility of performing a randomized clinical trial evaluating the effect of salpingectomy (removal of the fallopian tubes) during laparoscopic hysterectomy on ovarian function. The hypothesis is that removal of the tubes can prevent diseases of the fallopian tubes such as infection, hydrosalpinx (fluid-filled tubes)and additional invasive procedures such as further imaging work-ups and further surgery related to the tubes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2012
CompletedFirst Submitted
Initial submission to the registry
April 11, 2012
CompletedFirst Posted
Study publicly available on registry
April 17, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2013
CompletedApril 25, 2017
October 1, 2014
1.5 years
April 11, 2012
April 21, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline in ovarian function as measured by Anti-Mullerian Hormone (AMH)
AMH blood samples collected prior to surgery at day 1 (the day of the surgery) and at 1 and 3 months after day 1.
Secondary Outcomes (2)
Patient demographics
Prior to surgery
Patient surgical outcomes
Postoperatively on day 1
Study Arms (2)
Salpingectomy group
EXPERIMENTALParticipants in this group will have their fallopian tubes removed.
No Salpingectomy Group
NO INTERVENTIONParticipants in this group will not have their fallopian tubes removed.
Interventions
Eligibility Criteria
You may qualify if:
- Women ages 18-45 scheduled for laparoscopic hysterectomy with planned preservation of both ovaries.
You may not qualify if:
- Carrier for the gene that codes for breast cancer type 1 susceptibility protein (BRCA1) or the gene that codes for breast cancer type 2 susceptibility protein (BRCA 2).
- Personal history of gynecologic cancer
- Pregnancy
- Non-English speaking
- Unable to provide informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Division of Advanced Laparoscopy and Pelvic Pain, Department of Obstetrics and Gynecology, University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599, United States
Related Publications (1)
Findley AD, Siedhoff MT, Hobbs KA, Steege JF, Carey ET, McCall CA, Steiner AZ. Short-term effects of salpingectomy during laparoscopic hysterectomy on ovarian reserve: a pilot randomized controlled trial. Fertil Steril. 2013 Dec;100(6):1704-8. doi: 10.1016/j.fertnstert.2013.07.1997. Epub 2013 Aug 29.
PMID: 23993887DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Austin Findley, MD
University of North Carolina, Chapel Hill
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 11, 2012
First Posted
April 17, 2012
Study Start
April 1, 2012
Primary Completion
October 1, 2013
Study Completion
October 1, 2013
Last Updated
April 25, 2017
Record last verified: 2014-10