Psychological Traits, Sexuality and Quality of Life in Patients With Polycystic Ovary Syndrome

Hospital Clinic of Barcelona

Status: Unknown

Conditions: Polycystic Ovary Syndrome

Treatments: Diagnostic Test: SF-36 (Short Form Health Survey)

Study type: Observational

Funder types: Other

Identifiers

NCT03306459

B/2017/0614

Details and patient eligibility

About

A prospective assessment of psychological characteristics, quality of life and sexuality in naïve patients.

Full description

This project with PCOS patients include an assessment of quality of life and sexuality in naïve patients.

Hypothesizing that PCOS women would show higher rates of psychological alterations, this study is aimed to investigate the association between polycystic ovary syndrome (PCOS) and psychological disturbances, including anger and to analyze whether the biochemical/phenotypical features of PCOS may play a role in the type and severity of psychological disorders.

Enrollment: 60 estimated patients

Sex: Female

Ages: 16 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

PCOS patients without gestational desire who met the following criteria

• Oligomenorrhea (cycles lasting >35 days) or amenorrhea (no periods in 6 months)
• Hyperandrogenemia/hyperandrogenism Hirsutism Ferriman-Gallwey score > 12 Obvious acne or pronounced alopecia Androgen levels over normal female range

Exclusion criteria

• Prior psychiatric diagnosis
• Current use of psychiatric medications
• Difficulties with language comprehension in case of non-nationals.
• Yatrogenic hirsutism,
• Other endocrine deseases with hyperandrogenism or that may influence the final results Ovarian or adrenal neoplasia Prolactinoma Cushing's syndrome Congenital adrenal hyperplasia Diabetes mellitus Thromboembolic disease
• Patients who had received any drug therapy for hirsutism over the last 6 months

Trial design

60 participants in 2 patient groups

1/PCOS

Description:

The authors will select 30 PCOS patients who met the more strict and conservative Rotterdam diagnostic criteria (Rotterdam phenotype A) which include the presence of oligo-anovulation (cycles lasting \>35 days or amenorrhea) and hyperandrogenemia /hyperandrogenism (hirsutism or obvious acne or pronounced alopecia). All patients should have bilateral polycystic ovaries morphology on ultrasound. Additionally, the authors have decided to enroll PCOS patients that are all without pregnancy desire at the moment they fill out the questionnaires, in order to control for the potential confounding role of infertility on psychological outcomes. Different pituitary, adrenal, ovarian, thyroid or metabolic diseases will be excluded

Treatment:

Diagnostic Test: SF-36 (Short Form Health Survey)

2/CONTROL

Description:

The authors will enroll a control group of 30 women, age- matched with the PCOS women, from consecutive women controlled in the same outpatient clinic who met the following inclusion criteria: history of irregular menstrual cycle in absence of severe gynecologic and non-gynecologic diseases. This PCOS sample will be entirely constituted by women with no pregnancy desire; therefore, with the aim to limit the potential effect of the unfulfilled wish to conceive in the final results; additionally, infertile women will not admitted into the control group.

Treatment:

Diagnostic Test: SF-36 (Short Form Health Survey)