Sexual function in women with Polycystic Ovary Syndrome

Recruiting

Conditions: Polycystic Ovary Syndrome

Registration Number: NL-OMON24133

Lead Sponsor: Erasmus MC, Rotterdam

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 144

Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet all of the following criteria:

diagnosis of PCOS and age-matched controls (healthy women without PCOS).

Both women with PCOS and healthy women will be selected in a group not using hormonal contraceptives (for at least 3 months prior to the start of their participation in this research project) and a group using hormonal contraceptives for at least 3 months.

We aim to include as many women using OCP’s as not using OCP’s in both the PCOS group and the control group.

All participants need to be aged between 18 years – 40 years and be in a stable heterosexual relationship for at least 6 months.

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded from participation in this study:

In case of a psychiatric disorder, pregnancy or lactation, having undergone a radical hysterectomy or prolapse surgery, current or recent use of medication or medical disorders (other than PCOS) that are known to influence sexual response, with the exception of OCP’s.

In general:
No selection will be made based on the presence or absence of the wish to get pregnant or parity.

In case women do not want to participate in the psychophysiological part of the study, they will be excluded.

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.General sexual function as measured with the FSFI, SDI, FSDS-R<br>2.Genital sexual responsiveness (VPA) and self-reported ratings of subjective sexual responsiveness and affect (7 point Likert scale) from the psychophysiological measurements.

Secondary Outcome Measures

Name	Time	Method
1.The association between OCP use and general sexual function and genital sexual responsiveness.<br>2.The association between sexual parameters as measured with SESII-W, SPAQ and SES and general sexual function and genital sexual responsiveness.<br>3.Psychosocial parameters as measured with MBSRQ-AS, BISS, HADS, RSES and R-DAS<br>4.Steroid hormone levels (Testosterone, Sex Hormone Binding Globluline (SHBG) calculating Free Androgen Index: Testosterone x 100/SHBG), Oestradiol, Progesterone, Luteinizing-hormone (LH), FollicleStimulating-hormone (FSH), Androstedione, Dehydro-epiandrosterone (DHEA), Dehydro-epiandrosterone sulphate (DHEAS), Thyroid Stimulating Hormone (TSH), Prolactine, and fasting glucose and insulin)<br>5.Androgen receptor sensitivity as measured with CAG repeats