Sexual function in women with Polycystic Ovary Syndrome

Polycystic Ovary Syndrome (PCOS) is the most common endocrine disease in women
in the reproductive age and is often accompanied with changes in androgen
levels. It is associated with physical and psychological co-morbidities.
Treatment often consists of prescribing oral contraceptives (OCP), which
influence androgen levels. Androgen levels as well as other physical and
psychological factors influence sexual function. Studies concerning sexual
function in women with PCOS show conflicting results and often do not address
all contributing factors.

to assess general sexual functioning, genital sexual responsiveness,
subjective sexual responsiveness and affect in women with PCOS , and to make a
comparison of these results with the results of an age matched healthy control
group of women.

Additionally, to assess associations between OCP use, biopsychosocial
variables, endocrine features (sex steroid concentration), CAG repeat length,
BMI , biographical features and scores on psychosocial questionnaires (SESII-W,
SPAQ, SES, MBSRQ-AS, BISS, HADS, RSES, R-DAS) and general sexual functioning
and genital and subjective sexual responsiveness in women with PCOS and an age
matched healthy control group of women.

Case control study, observational prospective, multi-center.
Duration of the study: 3 years
Setting of the study: Academic Medical Clinics (Erasmus MC, LUMC, AMC)

Primary study aim
The difference between PCOS patients and healthy control women will be assessed
by sexological questionnaires (FSFI, SDI, FSDS-R) and psychophysiological
measurements (VPA) and self-reported subjective sexual responsiveness.

Participants will be subjected to an experimental session measuring genital
sexual responsiveness with photoplethysmography (VPA) and subjective sexual
responsiveness under 4 conditions of sexual stimuli. The stimuli that will be
used are 1) a fantasy only stimulus, 2) a vibratory only stimulus, 3) a
vibratory and film stimulus and 4) a film only stimulus.

Secondary study aims
Additionally for the secondary study aims PCOS patients and healthy control
women will be assessed by other sexological questionnaires (SESII-W, SPAQ,
SES) and other psychosocial and mental health questionnaires (MBSRQ-AS, BISS,
HADS, RSES, R-DAS). Scores on these questionnaires, endocrine features (sex
steroid levels), CAG repeat length, BMI, biographical and biopsychosocial
factors will be correlated with scores on FSFI, SDI, FSDS-R AND and VPA.

OCP users will be compared to non-OCP users on FSFI, SDI, FSDS-R and VPA
scores in both the PCOS patients and control women.

Independent variables are PCOS status and OCP use.
Dependent variables are general sexual function (measured with FSFI, FSDS-R,
SDI,SESII-W, SPAQ, SES) and genital and subjective sexual responsiveness
(measured with VPA).

The study will be performed in three phases.
First, we will compare general sexual function (FSFI, SDI, FSDS-R) and genital
(VPA) and subjective sexual responsiveness between PCOS women and healthy
control women irrespective of OCP use.
Second, we will compare scores on FSFI, SDI, FSDS-R and VPA between women
using OCP*s and women not using OCP*s, both PCOS patients and control women.
Third, we will compare general sexual function (FSFI, SDI, FSDS-R) and genital
(VPA) and subjective sexual responsiveness in PCOS women in a longitudinal
design assessing them first not using OCP*s and assessing them second after
using OCP*s for three months.

After a year, all participants will be asked to give consent to repeat the
endocrine screening in order to determine changes in the PCOS phenotype in the
same subject over time and to determine the reliability of the screening over
time.

This study is a multi-center study. The principal investigator (Pastoor) is
trained as a psychologist and sexologist. The Department of Obstetrics and
Gynaecology has proven research expertise in diagnosing, treating and
predicting treatment outcome in women with fertility problems especially in
those suffering from PCOS. Current research focuses, among others, on
life-style modification and on pathophysiological mechanisms of PCOS and their
genetic background.
Cooperation with LUMC (Both, Weijenborg) and AMC (Laan) is sought because of
their excellent and extended expertise in sexological research, both using
questionnaires and vaginal photoplethysmography.

There will be no benefits for the individual participants. However, the results
of the study will provide PCOS patients with more knowledge about their
condition, which might improve quality of life. The results of this study also
will be of clinical use for the education and treatment of women with PCOS.
Disadvantages might be the time invested in the participation in the study,
having to undergo one peripheral venous blood sample, having to fill in
questionnaires of an intimate nature, and having to undergo vaginal
measurements .
The vaginal photoplethysmograph used in this study is considered a save device.
No harmful events have been reported. The device will be sterilized before each
use. From previous studies at the LUMC and AMC it is known that the genital
measurement does not cause discomfort.