This trial is active, not recruiting.

Condition laparoscopic hysterectomy
Treatment salpingectomy
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

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose prevention
Participants in this group will have their fallopian tubes removed.
Removal of the fallopian tubes
(No Intervention)
Participants in this group will not have their fallopian tubes removed.

Primary Outcomes

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.

Secondary Outcomes

Patient demographics
time frame: Prior to surgery
Patient surgical outcomes
time frame: Postoperatively on day 1

Eligibility Criteria

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

Additional Information

Official title Effects of Salpingectomy During Laparoscopic Hysterectomy on Ovarian Function
Principal investigator Austin Findley, MD
Trial information was received from ClinicalTrials.gov and was last updated in November 2012.
Information provided to ClinicalTrials.gov by University of North Carolina, Chapel Hill.