NCT07423143

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,100

participants targeted

Target at P75+ for not_applicable

Timeline
383mo left

Started Mar 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress1%
Mar 2026Dec 2057

First Submitted

Initial submission to the registry

February 12, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 20, 2026

Completed
9 days until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2029

Expected
28.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2057

Last Updated

February 20, 2026

Status Verified

February 1, 2026

Enrollment Period

2.9 years

First QC Date

February 12, 2026

Last Update Submit

February 19, 2026

Conditions

MenopauseOpportunistic Salpingectomy

Keywords

opportunistic salpingectomyhysterectomynested trialrandomised controlled trialRCTfollicle-stimulating hormoneself-samplingdried blood spot cards

Outcome Measures

Primary Outcomes (1)

  • Age at menopause

    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 Outcomes (2)

  • Cardiovascular disease - CVD

    10-30 years after enrolment.

  • Mortality

    10-30 years after enrolment.

Study Arms (2)

Opportunistic salpingectomy

EXPERIMENTAL

Salpingectomy at the time of hysterectomy for a benign reason

Procedure: Opportunistic salpingectomy

No salpingectomy

NO INTERVENTION

No salpingectomy at hysterectomy for a benign reason

Interventions

Opportunistic salpingectomyPROCEDURE

Removal of the fallopian tubes at the time of hysterectomy

Opportunistic salpingectomy

Eligibility Criteria

Age20 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Umeå University

Umeå, 90346, Sweden

Location

Related Publications (8)

  • Muka T, Oliver-Williams C, Kunutsor S, Laven JS, Fauser BC, Chowdhury R, Kavousi M, Franco OH. Association of Age at Onset of Menopause and Time Since Onset of Menopause With Cardiovascular Outcomes, Intermediate Vascular Traits, and All-Cause Mortality: A Systematic Review and Meta-analysis. JAMA Cardiol. 2016 Oct 1;1(7):767-776. doi: 10.1001/jamacardio.2016.2415.

    PMID: 27627190BACKGROUND

  • Zhu D, Chung HF, Dobson AJ, Pandeya N, Giles GG, Bruinsma F, Brunner EJ, Kuh D, Hardy R, Avis NE, Gold EB, Derby CA, Matthews KA, Cade JE, Greenwood DC, Demakakos P, Brown DE, Sievert LL, Anderson D, Hayashi K, Lee JS, Mizunuma H, Tillin T, Simonsen MK, Adami HO, Weiderpass E, Mishra GD. Age at natural menopause and risk of incident cardiovascular disease: a pooled analysis of individual patient data. Lancet Public Health. 2019 Nov;4(11):e553-e564. doi: 10.1016/S2468-2667(19)30155-0. Epub 2019 Oct 3.

    PMID: 31588031BACKGROUND

  • van der Schouw YT, van der Graaf Y, Steyerberg EW, Eijkemans JC, Banga JD. Age at menopause as a risk factor for cardiovascular mortality. Lancet. 1996 Mar 16;347(9003):714-8. doi: 10.1016/s0140-6736(96)90075-6.

    PMID: 8602000BACKGROUND

  • Piek JM, Schauwaert J, Ellis LB, Zapardiel I, Planchamp F, Koblos K, Kacperczyk-Bartnik J, Bowden SJ, El Hajj H, Grigore M, Steenbeek MP, Bizzarri N, Kyrgiou M, Gultekin M. Opportunistic Salpingectomy for Prevention of Tubo-Ovarian Carcinoma: The European Society of Gynaecological Oncology Consensus Statements. JAMA. 2026 Mar 10;335(10):894-902. doi: 10.1001/jama.2025.24510.

    PMID: 41627806BACKGROUND

  • Idahl A, Darelius A, Sundfeldt K, Palsson M, Strandell A. Hysterectomy and opportunistic salpingectomy (HOPPSA): study protocol for a register-based randomized controlled trial. Trials. 2019 Jan 5;20(1):10. doi: 10.1186/s13063-018-3083-8.

    PMID: 30611296BACKGROUND

  • Idahl A, Liv P, Darelius A, Collins E, Sundfeldt K, Palsson M, Strandell A. HOPPSA update: changes in the study protocol of Hysterectomy and OPPortunistic SAlpingectomy, a registry-based randomized controlled trial. Trials. 2023 Mar 24;24(1):222. doi: 10.1186/s13063-023-07244-w.

    PMID: 36959664BACKGROUND

  • Magarakis L, Idahl A, Sundfeldt K, Liv P, Palsson M, Strandell A. SALpingectomy for STERilisation (SALSTER): study protocol for a Swedish multicentre register-based randomised controlled trial. BMJ Open. 2023 Sep 4;13(9):e071246. doi: 10.1136/bmjopen-2022-071246.

    PMID: 37666548BACKGROUND

  • Collins E, Strandell A, Granasen G, Idahl A. Menopausal symptoms and surgical complications after opportunistic bilateral salpingectomy, a register-based cohort study. Am J Obstet Gynecol. 2019 Jan;220(1):85.e1-85.e10. doi: 10.1016/j.ajog.2018.10.016. Epub 2018 Oct 12.

    PMID: 30321526BACKGROUND

Related Links

Study Officials

  • Annika Idahl, MD, PhD, Professor

    Umeå University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Annika Idahl, MD, PhD, Professor

CONTACT

+46 90 786 73 18annika.idahl@umu.se

Camilla Ersviken, Trial coordinator

CONTACT

mission-o.gyn@umu.se

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Masking is attempted to participants, but cannot be guaranteed due to the legal framework. Follicle-stimulating hormone will be measured with laboratory personnel unaware of participant allocation.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants in the randomised controlled trial HOPPSA (NCT03045965) will be recruited to collect a blood sample by self-sampling twice one year apart.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 12, 2026

First Posted

February 20, 2026

Study Start

March 1, 2026

Primary Completion (Estimated)

February 1, 2029

Study Completion (Estimated)

December 1, 2057

Last Updated

February 20, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

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.

Locations

SE(1)