Effects of Salpingectomy During Laparoscopic Hysterectomy on Ovarian Function
This trial is active, not recruiting.
|Sponsor||University of North Carolina, Chapel Hill|
|Start date||April 2012|
|End date||October 2013|
|Trial size||30 participants|
|Trial identifier||NCT01578759, 12-0440|
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.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
|Masking||single blind (subject)|
Participants in this group will have their fallopian tubes removed.
Participants in this group will not have their fallopian tubes removed.
Change from baseline in ovarian function as measured by Anti-Mullerian Hormone (AMH)
time frame: AMH blood samples collected prior to surgery at day 1 (the day of the surgery) and at 1 and 3 months after day 1.
time frame: Prior to surgery
Patient surgical outcomes
time frame: Postoperatively on day 1
Female participants from 18 years up to 45 years old.
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
|Official title||Effects of Salpingectomy During Laparoscopic Hysterectomy on Ovarian Function|
|Principal investigator||Austin Findley, MD|
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