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Effects of Salpingectomy During Laparoscopic Hysterectomy on Ovarian Function

Effects of Salpingectomy During Laparoscopic Hysterectomy on Ovarian Function

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01578759
Enrollment
30
Registered
2012-04-17
Start date
2012-04-30
Completion date
2013-10-31
Last updated
2017-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Laparoscopic Hysterectomy

Keywords

ovarian function tests

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.

Interventions

PROCEDURESalpingectomy

Removal of the fallopian tubes

Sponsors

University of North Carolina, Chapel Hill
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No

Inclusion criteria

* Women ages 18-45 scheduled for laparoscopic hysterectomy with planned preservation of both ovaries.

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frameDescription
Patient demographicsPrior to surgeryThe following routinely collected information will be included in the data analysis: age, body mass index, and surgery indication.
Patient surgical outcomesPostoperatively on day 1The following surgical outcomes will be collected postoperatively: total operating time, estimated blood loss, surgical complications, and surgical pathology.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026