Hormonal regulation of cardiometabolic health after oophorectomy
HoCa - A Multidimensional Study on Menopausal Hormonal Change, Cardiometabolic Health and Embodied Experience
We will see how losing ovarian function after oophorectomy affects quality of life, heart and metabolic health, brain function, and fat tissue in women aged 35–50.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 35 Years to 50 Years |
| Sex | Female |
| Sponsor | University of Jyvaskyla Academic / other |
| Locations | 7 sites (Helsinki and 6 other locations) |
| Trial ID | NCT07406412 on ClinicalTrials.gov |
What this trial studies
This longitudinal observational study follows women aged 35–50 who are planning oophorectomy, with assessments before surgery and at 1–2 months and 12 months after surgery. Participants complete validated questionnaires, physiological and neuromuscular tests, vascular and exercise assessments, and blood sampling at rest and after a standardized cycle ergometer test. Subgroups take part in qualitative interviews and some donate adipose tissue during surgery for exploratory cellular analyses. Whether participants begin hormone replacement therapy as part of routine care will be recorded and explored as a factor that may influence 12-month outcomes.
Who should consider this trial
Good fit: Women aged 35–50 who are pre- or perimenopausal, have one or two functional ovaries, and are planning oophorectomy or salpingo-oophorectomy for non-malignant reasons and are not currently on systemic estrogen-containing medication.
Not a fit: Women undergoing oophorectomy for ovarian cancer or other malignant conditions, those already taking systemic estrogen, and individuals with severe heart or liver disease or mobility limitations that prevent physiologic testing are unlikely to be eligible for or to benefit from the full physiologic components of the protocol.
Why it matters
Potential benefit: If successful, the findings could help personalize post-oophorectomy care and guide decisions about hormone replacement to protect cardiometabolic, neurological, and quality-of-life outcomes.
How similar studies have performed: Previous research has linked surgical menopause to cardiometabolic and cognitive changes, but this comprehensive longitudinal approach that includes adipose tissue cellular analysis is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Oophorectomy due to ovarian cancer or other malignant conditions * Current systemic estrogen-containing medication The following exclusion criteria apply only to participation in physiological assessments (not questionnaires or interviews): * Severe heart or liver disease * Mobility limitations that prevent participation in physical exercise tests The following factors do not lead to exclusion but will be recorded and considered in analyses: * Use of medications such as weight reduction drugs, lipid-lowering agents, or antihypertensives * Concomitant hysterectomy or other surgeries performed with oophorectomy * Use of local vaginal oestrogen therapy * Initiation of systemic hormone replacement therapy (HRT) after the 1-2-month post-surgery assessments (allowed according to clinical need; not part of the study protocol)
Where this trial is running
Helsinki and 6 other locations
- Hus — Helsinki, Finland (Not_yet_recruiting)
- University of Jyväskylä — Jyväskylä, Finland (Active_not_recruiting)
- Wellbeing Services County of Central Finland — Jyväskylä, Finland (Recruiting)
- Wellbeing Services County of North Savo — Kuopio, Finland (Recruiting)
- Wellbeing Services County of North Ostrobothnia — Oulu, Finland (Not_yet_recruiting)
- Wellbeing Services County of Pirkanmaa — Tampere, Finland (Recruiting)
- Wellbeing Services County of Southwest Finland — Turku, Finland (Recruiting)
Study contacts
- Principal investigator: Eija K Laakkonen, Associate Professor — University of Jyvaskyla
- Study coordinator: Eija K Laakkonen, Associate Professor
- Email: eija.k.laakkonen@jyu.fi
- Phone: +358-40-8053588
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.