Mirena® IUD's Effect on Fallopian Tube Fimbriae and Ovarian Cortical Inclusion Cyst Cell Proliferation

Combination-type oral contraceptives (COCs) have been shown to significantly reduce the risk of invasive epithelial ovarian cancer (IEOC); this protective effect may be achieved to a large extent through COCs ability to reduce cell proliferation in the fallopian tube fimbriae (FTF). The progestin-releasing Mirena® intra-uterine device (IUD) is an increasingly popular method of contraception, but it is not known if its use will reduce a woman's risk of IEOC. Mirena® use does not block ovulation in most women but it may release sufficient progestin to also reduce cell proliferation in the FTF. This study aims to evaluate the effects of the Mirena® IUD on cell proliferation in the FTF as a possible biomarker of protection against IEOC.

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Key information

Conditions

Epithelial Ovarian Cancer Adnexal Diseases Carcinoma Carcinoma, Ovarian Epithelial Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Ovarian Diseases Ovarian Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

35 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Memorial Sloan Kettering Basking Ridge, Basking Ridge, New Jersey, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Women between 35 and 50 years of age (inclusive)
Women who will be scheduled to undergo an RRSO or RRs
Women who will have at least one fallopian tube removed for risk-reducing reasons (with or without removal of ovar(ies))
Women who are willing to have a Mirena® IUD inserted at least prior to risk-reducing surgery or who already have the Mirena® in place
Women using non-hormonal forms of contraception (Note: If a copper IUD is being used, the IUD must be removed prior to or at time of Mirena insertion.)

Exclusion criteria

Any medical contraindication to use of a Mirena® IUD, including:

Pregnancy (a pregnancy test is required prior to study entry)
Known uterine anomaly that distorts the shape of the uterine cavity
Acute pelvic inflammatory disease
Postpartum endometritis or endometrial infection
Known or suspected uterine or cervical neoplasia
Known history or suspected breast cancer or other progestin-sensitive cancer
Uterine bleeding of unknown etiology.
Untreated acute cervicitis, vaginitis, or other lower genital tract infections
Acute liver disease or liver tumor (benign or malignant)
Use of tamoxifen, raloxifene, or chemotherapy within the previous 6 months
Positive pregnancy test
Breastfeeding
Use of a copper IUD if the patient is not willing to have it removed prior to surgery and replaced with a Mirena® IUD

Treatment and study plan

Mirena® intra-uterine device (IUD)

Device

In this study, a Mirena® IUD will be inserted into volunteers scheduled for a risk-reducing salpingo-oophorectomy (RRSO) or risk-reducing salpingectomy (RRS) at Memorial Sloan Kettering Cancer Center (MSK). Alternatively, women with a Mirena® IUD already in place and who will be scheduled for an RRSO or RRS at MSK can also participate. We are seeking 14 evaluable participants. FTF tissue (and ovarian inclusion cyst tissue, when available) collected at the time of risk-reducing salpingectomy (RRS) will be tested by immunochemistry staining for Ki67 (a protein that is significantly increased when cells are preparing for division).

Primary outcomes

Cell Proliferation in the Fallopian Tube Fimbriae as Measured by Ki-67%+

Time frame: 1 year

Women will be deemed evaluable for this primary outcome if they successfully underwent placement of the Mirena® IUD, received a RRSO or RRS as planned, and had a P4 value ≤1 ng/ml.

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Important dates

Study start: 2015
Primary completion: 2022
Study completion: 2022
First posted: Jun 22, 2015
Registry last updated: Oct 16, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed