To demonstrate the presence of a reduced age specific ovarian reserve status in BRCA mutation carriers by:1. using serum AMH as ovarian reserve status test. 2. using the antral follicle count (AFC) as ovarian reserve test3. using ovarian response to…
ID
Source
Brief title
Condition
- Menopause related conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Ovarian ageing measured by serum AMH levels.
Secondary outcome
Antral follicle count
Ovarian response (oocytes yielded, MII ooocytes, poor response)
Clinical pregnancy rate
Ongoing pregnancy rate
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
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 assessing the ovarian reserve by using three different
parameters (AMH, AFC and ovarian response) we will be able to study the effect
of BRCA mutations on ovarian ageing,
The primary hypothesis is that normo-ovulatory women with a deleterious BRCA
mutation have lower levels of AMH compared to normal controls, with at least a
difference of 0.90 ng/ml, suggesting an effect size of approximately five years
in menopausal age.
Study objective
To demonstrate the presence of a reduced age specific ovarian reserve status in
BRCA mutation carriers by:
1. using serum AMH as ovarian reserve status test.
2. using the antral follicle count (AFC) as ovarian reserve test
3. using ovarian response to ovarian hyperstimulation for IVF as proxy variable
of ovarian reserve status.
Study design
International, multicenter and observational study with an invasive
measurement (serum sampling)
Study burden and risks
The risks associated with participation are negligible.
Heidelberglaan 100
Utrecht 3508GA
NL
Heidelberglaan 100
Utrecht 3508GA
NL
Listed location countries
Age
Inclusion criteria
Case group:
Female age * 40 years
Regular menstrual cycles (i.e. mean cycle length of 21-35 days)
First IVF with ICSI and PGD treatment cycle due to a female pathogenic BRCA mutation
Written informed consent;Control group:
Female age * 18 years and * 40 years
Regular menstrual cycles (i.e. mean cycle length of 21-35 days, with the next menstrual period predictable within a 7 days* time frame)
First IVF with ICSI and PGD treatment cycle due to an indication unsuspected for reduced ovarian reserve status
Written informed consent
Exclusion criteria
Case group:
Ovarian surgery
Chemotherapy
Radiation therapy to the pelvis, lower abdomen or total body radiation
Known female endocrine or autoimmune abnormalities (i.e. Cushing syndrome, type I Diabetes Mellitus, hypothyroidism, hyperprolactinemia, adrenal insufficiency, hypoparathyriodism, myasthenia gravis, rheumatoid arthritis, systemic lupus erythematosus)
Body Mass Index > 30 kg/m2
Polycystic Ovarian Syndrome (Rotterdam criteria)
Early follicular FSH > 15 IU/L
Known HIV infection
Known genetic abnormalities, suspected for subfertility (structural or numerical abnormalities of the X-chromosome (i.e. Turner*s syndrome, fragile X syndrome), or abnormalities of human autosomal functionally relevant genes suspected for subfertility, other than a BRCA mutation. ;Control group:
Ovarian surgery
Chemotherapy
Radiation therapy to the pelvis, lower abdomen or total body radiation
Known female endocrine or autoimmune abnormalities (i.e. Cushing syndrome, type I Diabetes Mellitus, hypothyroidism, hyperprolactinemia, adrenal insufficiency, hypoparathyriodism, myasthenia gravis, rheumatoid arthritis, systemic lupus erythematosus)
Body Mass Index > 30 kg/m2
Polycystic Ovarian Syndrome (Rotterdam criteria)
Early follicular FSH > 15 IU/L
Known HIV infection
Known genetic abnormalities, suspected for subfertility (structural or numerical abnormalities of the X-chromosome (i.e. Turner*s syndrome, fragile X syndrome), or abnormalities on human autosomal functionally relevant genes suspected for subfertility.
PGD requested for structural chromosomal abnormalities
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 | NL45629.041.14 |