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
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