Primary objective: To confirm that a BRCA-mutation is a determinant of advanced ovarian ageing by using serum-AMH as ovarian reserve test.Secondary objective: To confirm that a BRCA-mutation is a determinant of reduced reproductive health/outcome.
ID
Source
Brief title
Condition
- Menopause related conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Ovarian ageing, measured by age specific serum AMH level.
Secondary outcome
Reproductive health/outcome, which is measured by:
- subfertility
- fertility treatment
- parity
- miscarriage/abortion
- life birth (and gender outcome)
- pregnancy success rate (number of pregnancies/ amount of life birth)
Background summary
Timing of menopause is associated with preceding infertility and multiple
women*s health risks, such as breast, endometrial and ovarian cancer,
osteoporosis, cardiovascular diseases, cognition, sexual health and general
well being. Therefore, studies on factors that determine age at menopause or
ovarian ageing can help us unravel the underlying biological pathways and the
mechanisms of the associated infertility and health risks.
In recent literature, there remains uncertainty about the impact of BRCA gene
mutations on ovarian reserve and age of natural menopause.
In the current study, by comparing serum AMH levels between cohorts of
normo-ovulatory BRCA (BReast CAncer) mutation-positive women and
normo-ovulatory controls, we will be able to study the effect of BRCA mutations
on ovarian ageing.
The primary hypothesis is that normo-ovulatory women with a BRCA gene mutation
have lower levels of AMH compared to normo-ovulatory BRCA mutation negative
women, with at least a difference of 0.40 ng/ml, suggesting an effect size of
three years in menopausal age.
Study objective
Primary objective: To confirm that a BRCA-mutation is a determinant of
advanced ovarian ageing by using serum-AMH as ovarian reserve test.
Secondary objective: To confirm that a BRCA-mutation is a determinant of
reduced reproductive health/outcome.
Study design
Cross-sectional and multi-center.
Study burden and risks
The risks associated with participation are negligible. For the prospectively
approached group, blood sampling for measuring the AMH level can be done in
once with taken the blood sample for genetic testing. For the retrospectively
approached group, one extra visit to the hospital is necessary for blood
sampling. Furthermore, the questionnaire is not likely to provide psychological
injury.
Heidelberglaan 100
3584 CX Utrecht
NL
Heidelberglaan 100
3584 CX Utrecht
NL
Listed location countries
Age
Inclusion criteria
Female with an age ranging between 18-45 years
Women with predictive genetic testing on BRCA mutation due to family history, or women with a known BRCA mutation carrier status
regular menstrual cylce
written informed consent
Exclusion criteria
surgical menopause
ovarian surgery
chemo-or radiation therapy
Known human immunodeficiency virus (HIV) infection
Known endocrine or autoimmune abnormalities
genetic abnormalities, others than a BRCA mutation, associated with primary ovarian insufficiency
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL37461.041.11 |