This clinical trial studies the effects of the levonorgestrel-releasing intrauterine device on the cells in the fallopian tube (the channel connecting the ovary to the uterus) and on cysts within the ovaries in patients undergoing salpingo-oophorectomy (surgical removal of the fallopian tubes and ovaries). Most ovarian cancers start in the fallopian tube or in cysts within the ovaries. The intrauterine device releases a small amount of the hormone levonorgestrel, a synthetic version of progesterone, into the uterus every day. This device may help protect against ovarian cancer by reducing the level of cell activity in the fallopian tube and in ovarian cysts.
Additional locations may be listed on ClinicalTrials.gov for NCT02477202.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVES:
I. To determine in women undergoing a risk-reducing salpingo-oophorectomy (RRSO) or risk-reducing salpingectomy (RRS) at Memorial Sloan-Kettering (MSK) whether cell proliferation in the fallopian tube fimbriae (FTF) is reduced in those using a progestin-releasing Mirena intrauterine device (IUD) (levonorgestrel-releasing intrauterine device) compared to such proliferation during the normal menstrual cycle.
SECONDARY OBJECTIVES:
I. To determine in women undergoing an RRSO at MSK whether cell proliferation in ovarian cortical inclusion cysts (CICs) is reduced in those using a progestin-releasing Mirena IUD compared to such proliferation during the normal menstrual cycle.
OUTLINE:
Participants that do not already have the levonorgestrel-releasing intrauterine device in place undergo insertion of the levonorgestrel-releasing intrauterine device at least 10 days before undergoing a RRSO or RRS. The IUD is removed at the time of surgery.
Trial PhaseNo phase specified
Trial Typeprevention
Lead OrganizationMemorial Sloan Kettering Cancer Center
Principal InvestigatorDennis S. Chi