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Menopausal Impact of Opportunistic Salpingectomy for Ovarian Cancer Prevention

ConditionsMenopauseOpportunistic Salpingectomy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age20-65
SponsorUmeå University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Ongoing systemic hormonal treatment using sex steroids

Bilateral oophorectomy

Cancer treatment affecting ovarian function

Other treatments with major effects on ovarian function

Trial design

Design model

Parallel

Treatments tested in this trial

  • Opportunistic salpingectomy

    Procedure/Surgery

    Removal of the fallopian tubes at the time of hysterectomy

Treatment groups

2,100 Participants
are divided into 2 treatment groups
Group A: Opportunistic salpingectomyExperimental treatment 1 intervention
Group B: No salpingectomyNo intervention 0 interventions

Trial outcomes

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.

Time frame
1 year

Secondary outcomes

1

Cardiovascular disease - CVD

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.

Time frame
10-30 years after enrolment.
2

Mortality

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.

Time frame
10-30 years after enrolment.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Umeå University

Lead sponsor

Uppsala University

Collaborator

Karolinska Institutet

Collaborator

Örebro University, Sweden

Collaborator

Queen Mary University of London

Collaborator

Region Västerbotten

Collaborator

Göteborg University

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: