Skip to content

Sexual function in women with Polycystic Ovary Syndrome

Sexual function in women with Polycystic Ovary Syndrome

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON24133
Enrollment
144
Registered
2019-03-05
Start date
2017-02-19
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Polycystic Ovary Syndrome

Interventions

None listed

Sponsors

Erasmus MC, Rotterdam
Lead Sponsor

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

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

Secondary

MeasureTime frame
1. The association between OCP use and general sexual function and genital sexual responsiveness. 2. The association between sexual parameters as measured with SESII-W, SPAQ and SES and general sexual function and genital sexual responsiveness. 3. Psychosocial parameters as measured with MBSRQ-AS, BISS, HADS, RSES and R-DAS 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) 5. Androgen receptor sensitivity as measured with CAG repeats

Contacts

Public ContactHester Pastoor

Erasmus MC

h.pastoor@erasmusmc.nl0031617048767

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)