Sexual function in women with Polycystic Ovary Syndrome

Rationale: 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.
Objective: 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.
Study design: case control study, observational prospective, multi-center
Study population: PCOS patients, 18-40 years old. Control population of age matched healthy women. All women have to be in a stable heterosexual relationship for at least 6 months. In both groups we aim at including as many women using OCP’s as not using OCP’s.
Main study parameters/endpoints:
General sexual functioning: Female Sexual Function Index (FSFI), Sexual Desire Inventory (SDI), Female Sexual Distress Scale-Revised (FSDS-R).
Genital sexual arousal: vaginal pulse amplitude (VPA) measured with photoplethysmography during an experimental session with different erotic stimuli: a self-induced erotic fantasy, a vibration only stimulus, erotic film only and vibratory stimulation combined with erotic film.
Subjective sexual arousal and affect: self-reported ratings of sexual arousal and positive and negative affect collected after each stimulus condition.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: 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.

Hypotheses following from the literature:
Primary hypotheses:
- we expect to find impaired results in PCOS patients compared with normal controls on the following subjective measures of sexual function: FSFI, SDI, FSDS-R
- we expect to find higher responses in PCOS patients than in normal controls on genital and subjective sexual responsiveness measured with VPA in both the fantasy only and vibratory only conditions

Secondary hypotheses:
- We expect PCOS women not using OCP’s (i.e. with hyperandrogenism) to show higher levels of VPA response in the fantasy only and vibratory only conditions than PCOS women on OCPs and normal controls with or without OCP. Control women using OCP’s are expected to show the lowest VPA levels in these two conditions .
- We expect to find no differences in VPA response between PCOS patients and normal controls during film conditions.
- We expect women with PCOS to show impaired results and higher distress levels as measured with SESII-W, SPAQ, SES, MBSRQ-AS,BISS, HADS, RSES, R-DAS compared with control women.
o We expect these scores to be associated with impaired scores on FSFI, SDI and FSDS-R, but not with VPA scores.
- We do not expect to find an association between endocrine features and scores on FSFI, SDI and FSDS-R in both the PCOS patients and control women.
- We expect to find a stronger positive correlation between endocrine features (sex steroid concentrations) and VPA scores in the fantasy only and vibration only condition in PCOS women but not in control women.
- We expect to find better sexual function (FSFI, SDI, FSDS-R, VPA) in women with either longer or shorter CAG repeat length in both the PCOS patients and the control women.

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