Menopausal Impact of Opportunistic Salpingectomy for Ovarian Cancer Prevention (MISSION-O)

February 19, 2026 updated by: Umeå University

The goal of this clinical trial is to find out whether removing the fallopian tubes at the time of hysterectomy leads to an earlier menopause. The study includes women under 55 years of age who previously underwent hysterectomy as participants in the HOPPSA trial, where they were randomly assigned to either removal of the fallopian tubes or no removal.

The main question is:

• Does removing the fallopian tubes at the time of hysterectomy lead to an earlier menopause? Researchers will compare women who had their fallopian tubes removed during hysterectomy with women who had hysterectomy alone to see whether menopause occurs earlier after tube removal. Age at menopause will be estimated by measuring follicle-stimulating hormone (FSH) in small blood samples collected on a paper card.

Participants will:

  • Collect 4-5 drops of blood using a finger prick
  • Place the drops on a paper card and mail it to the researchers
  • Complete an online questionnaire These steps will be done twice, one year apart.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Opportunistic salpingectomy, defined as removal of the fallopian tubes during gynaecologic surgery performed for another indication, has been proposed as a strategy to reduce the risk of ovarian cancer. This approach is supported by accumulating evidence that many high-grade serous ovarian cancers originate in the distal fallopian tube. Although short-term surgical safety has been evaluated in randomized and observational studies, uncertainty remains regarding possible long-term effects on ovarian function.

The HOPPSA randomized trial was initiated to evaluate outcomes after hysterectomy with or without salpingectomy in women undergoing surgery for benign conditions. Previous analyses from this cohort have focused on perioperative safety and patient-reported outcomes. However, the effect of salpingectomy on the timing of menopause has not yet been determined. This question is clinically important because epidemiologic evidence shows that earlier menopause is associated with increased risks of cardiovascular mortality and all-cause mortality, with approximately a 2% relative increase in risk per year earlier menopause. Earlier menopause has also been associated with increased risks of osteoporosis, neurocognitive symptoms, sexual dysfunction, and reduced quality of life. Even modest shifts in menopausal timing could therefore have clinically meaningful long-term health implications.

The relevance of this knowledge gap is underscored by the relatively low lifetime risk of epithelial ovarian cancer in the general population, estimated at approximately 1.3-2%. Modelling studies suggest that between 96 and 148 opportunistic salpingectomy procedures may be required to prevent one ovarian cancer case. Consequently, even small changes in menopausal timing, if present, could influence the overall balance of benefits and risks associated with preventive salpingectomy.

Assessment of menopausal timing after hysterectomy presents methodological challenges because menstrual history cannot be used. Biochemical markers are therefore required. Follicle-stimulating hormone (FSH) is a well-established indicator of ovarian aging and menopausal transition, reflecting declining ovarian follicular activity. Measurement of FSH in blood samples enables estimation of menopausal timing independent of menstrual data.

Capillary blood sampling using self-collected dried blood spots enables biologic measurements in large populations without requiring clinic visits. This approach has been validated for hormone analyses and facilitates long-term follow-up with reduced logistical constraints, thereby supporting high participation and minimizing attrition in longitudinal studies, an important consideration for unbiased estimation of long-term outcomes.

The MISSION-O study uses extended follow-up of participants previously enrolled in the HOPPSA randomized trial to determine whether salpingectomy influences age at menopause. By leveraging a randomized surgical cohort with long-term biologic assessment, this study aims to generate robust evidence regarding the endocrine safety of opportunistic salpingectomy. The findings are expected to inform clinical counselling, individualized risk-benefit assessment, and future clinical guidelines regarding preventive salpingectomy at the time of gynaecologic surgery.

Study Type

Interventional

Enrollment (Estimated)

2100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Annika Idahl, MD, PhD, Professor
  • Phone Number: +46 90 786 73 18
  • Email: annika.idahl@umu.se

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Having had hysterectomy for a benign indication
  • Less than 55 years at surgery
  • Was included in the ITT population of the HOPPSA register-based randomised controlled trial (R-RCT) of opportunistic salpingectomy
  • Informed consent

Exclusion Criteria:

  • Ongoing systemic hormonal treatment using sex steroids
  • Bilateral oophorectomy
  • Cancer treatment affecting ovarian function
  • Other treatments with major effects on ovarian function

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Opportunistic salpingectomy
Salpingectomy at the time of hysterectomy for a benign reason
Procedure: Opportunistic salpingectomy
Removal of the fallopian tubes at the time of hysterectomy
No Intervention: No salpingectomy
No salpingectomy at hysterectomy for a benign reason

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Age at menopause
Time Frame: 1 year
Evaluated using serum follicle-stimulating hormone (FSH) levels analysed in self-sampled dried blood spots. Continuous outcome measured in years. Samples collected twice one year apart.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiovascular disease - CVD
Time Frame: 10-30 years after enrolment.
Dichotomous outcome. Diagnosis will be classified according to ICD-10. Data from national health registers will be retrieved. The outcome will be further described according to types of cardiovascular disease, i.e. coronary heart disease and stroke, as well as age at CVD.
10-30 years after enrolment.
Mortality
Time Frame: 10-30 years after enrolment.
Dichotomous outcome, the diagnosis is classified according to ICD-10. Data retrieved from the national Cause of Death Register. Mortality will be further described as all-cause mortality, and mortality due to cardio-vascular disease.
10-30 years after enrolment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Umeå University

Collaborators

Karolinska Institutet
Uppsala University
Göteborg University
Queen Mary University of London
Örebro University, Sweden
Region Västerbotten

Investigators

  • Principal Investigator: Annika Idahl, MD, PhD, Professor, Umeå University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2026

Primary Completion (Estimated)

February 1, 2029

Study Completion (Estimated)

December 1, 2057

Study Registration Dates

First Submitted

February 12, 2026

First Submitted That Met QC Criteria

February 19, 2026

First Posted (Actual)

February 20, 2026

Study Record Updates

Last Update Posted (Actual)

February 20, 2026

Last Update Submitted That Met QC Criteria

February 19, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • MISSION-O-26
  • 2024-06333 (Other Grant/Funding Number: The Swedish Research Council)
  • RV-1004811 (Other Grant/Funding Number: Region Västerbotten)
  • Dnr. 2025-08086-01 (Other Identifier: The Swedish Ethical Review Authority)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Under Swedish law, individual-level health data containing potentially identifiable and sensitive patient information cannot be shared publicly. Metadata will be published in a research data repository. Researchers may request access to the data; such requests will be subject to a formal secrecy assessment in accordance with the Swedish Act on Public Access to Information and Secrecy (2009:400) and applicable ethical approvals.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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