1. Evaluation of gene-expression profiles of endometria of PCOS women compared to normal ovulatory women2. Identify genes and pathways which contribute to a high rate of miscarriages of PCOS women3. Identify genes and pathways related to the high…
ID
Source
Brief title
Condition
- Ovarian and fallopian tube disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Determine endometrial gene-expression profiles from women with a normal
regular cycle and from PCOS women
- Determine basal levels for E2, LH, FSH, AMH, prolactin, free testosterone,
SHBG, DHEA-S, and 17-hydroxyprogesterone (17-OHP) of control patients and PCOS
patients
- Identify endometrial genes and pathways contributing to PCOS related
infertility.
Secondary outcome
Not applicable
Background summary
PCOS (Polycystic Ovary Syndrome) is a common endocrine and metabolic disorder
in women in the reproductive age. It is the most common cause of anovulatory
infertility, and its prevalence is estimated to be 5-10%.
The currently accepted definition of PCOS involves the combination of at least
two of the following features: chronic anovulation, clinical or
endocrinological signs of hyperandrogonism and polycystic ovaries (PCO)
assessed by ultrasound.
Women with PCOS have a lower fecundity rate. Infertility associated with PCOS
derives from chronic anovulation, but there are increasing data suggesting that
poor oöcyt quality, implantation failure, and higher rates of miscarriage
further complicate achieving and maintaining a pregnancy in women with PCOS.
Miscarriage rates have been reported to be between 30 and 50%, and 30% of women
with recurrent miscarriages are reported to have PCOS. Moreover, PCOS women
have a significantly higher risk of endometrial hyperplasia and endometrial
cancer. If these women develop endometrial cancer it is at an earlier age as
compared to non PCOS women (mean age 40 compared to 64 years of age).
The endometrium is the inner layer of the uterus, and undergoes a rapid cycling
process of proliferation, differentiation and cell death due to do the
production of the ovarian hormones, estrogen and progesterone. In women with
PCOS who are anovulatory, the regulatory roles of progesterone and progesterone
withdrawal in the endometrium is absent or suboptimal. As a result, the tissue
is continuously exposed to estrogens, and does not undergo the sequential
changes in gene expression and associated biochemical processes resulting in
normal endometrial cellular proliferation, differentiation, and tissue
desquamation. There is increasing evidence of dysregulated expression of
biomarkers in the epithelium of the endometrium of women with PCOS, for example
αvβ3 integrin, ERα and a dysregulation in the IGF (insulin-like growth factor)
system.
The aim of this study is to understand dysregulated signalling pathways in the
endometrium of PCOS women by analyzing expression profiles using a
pathway-oriented method.
Study objective
1. Evaluation of gene-expression profiles of endometria of PCOS women compared
to normal ovulatory women
2. Identify genes and pathways which contribute to a high rate of miscarriages
of PCOS women
3. Identify genes and pathways related to the high incidence of endometrial
cancer in PCOS women
Study design
The study is an analysis of endometrial gene-expression profiles of PCOS
patients and normal ovulatory control women.
Study burden and risks
Risk and burden are linked to protocol procedures, such as blood withdrawal,
ultrasound and biopsy sampling. Although these are routine procedures, carried
out by medical qualified personnel, they may cause side effects or discomfort
to the subject. However, it is expected that these procedures will generally be
well tolerated.
The patient is asked to come once to the hospital and a questionnaire is send
to her. At the study visit the blood and endometrium samples are collected, and
the ultrasound is performed.
s'Gravendijkwal 230
Rotterdam 3015 CE
NL
s'Gravendijkwal 230
Rotterdam 3015 CE
NL
Listed location countries
Age
Inclusion criteria
- Regular menstrual cycle (between 25 and 35 days)
- BMI >18 and <27
- Age 18 and above
- normal serum FSH levels (1-10 IE/l)
- normal serum prolactin levels (<1 U/l)
- normal TSH levels (0.2-4.2 mU/l)
- normal internal genitals as observed by ultrasound
Exclusion criteria
Women which are diagnosed with endometriosis (based on clinical findings, questionair, gynaecological examination, transvaginal ultrasound or laparoscopy).
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 | NL28923.078.09 |