Hormonal Regulation of Cardiometabolic Health Study

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age35-50
SponsorUniversity of Jyvaskyla

About this trial

The goal of this observational study is to understand how the loss of ovarian function after oophorectomy affects the health and well being of women aged 35-50.

The study focuses on four areas:

1. Quality of life and embodied experience, 2. Cardiometabolic health, 3. Central nervous system function, and 4. Adipose tissue health and cellular function.

Our primary goal is to understand the effects of oophorectomy on women's health in focus areas 1 to 3. To do this, we will compare women's health before surgery with follow up assessments at 1-2 months and 12 months after surgery. Some participants may start hormone replacement therapy (HRT) during follow up as part of their routine care; this is outside the study protocol. As an exploratory aim, we will examine whether 12 month outcomes-or the change from baseline to 12 months-differ between participants who begin HRT and those who do not.

Focus area 4 provides an opportunity to explore how molecular and cellular mechanisms in adipose tissue respond to the loss of ovarian hormones. These analyses are exploratory and intended to offer mechanistic insight rather than clinical endpoints.

Participants will:

* undergo bilateral (or unilateral, if only one ovary remains) oophorectomy as part of their clinical treatment, * complete questionnaires and physiological measurements at three time points, * a subgroup will participate in qualitative interviews about their lived experience of surgical menopause, * and a subgroup will volunteer adipose tissue samples collected during surgery.

Eligibility criteria

Qualifiers

Age 35-50 years

Pre- or perimenopausal status (defined as self-reported menstrual bleedings and/or follicle-stimulating hormone ≤25 IU/L)

One or two functional ovaries

Planning to undergo bilateral oophorectomy or salpingo-oophorectomy (BSO) or unilateral oophorectomy or salpingo-oophorectomy (SO) if the other ovary has been previously removed, for non-malignant reasons

Disqualifiers

Oophorectomy due to ovarian cancer or other malignant conditions

Current systemic estrogen-containing medication

Severe heart or liver disease

Mobility limitations that prevent participation in physical exercise tests

Trial design

Treatments tested in this trial

  • Surgical removal of ovaries
  • Hormone Replacement Therapy (HRT)

Treatment groups

120 Participants
are divided into 1 treatment group

Sponsors and collaborators

University of Jyvaskyla

Lead sponsor

Wellbeing Services County of Central Finland

Collaborator

Wellbeing Services County of North Savo

Collaborator

Wellbeing Services County of Pirkanmaa

Collaborator

Wellbeing Services County of Southwest Finland

Collaborator

Wellbeing Services County of North Ostrobothnia

Collaborator

Hospital District of Helsinki and Uusimaa

Collaborator