Clinical trial NCT03306459: Psychological Traits, Sexuality and Quality of Life in Patients With Polycystic Ovary Syndrome
Official title: Hospital Clínic Barcelona
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Polycystic Ovary Syndrome
Keywords: PCOS
Quality of life
Sexuality
Psychological traits
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
First posted: 2017-10-11
Enrollment: 60
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The authors will select 30 PCOS patients who met the more strict and conservative Rotterdam diagnostic criteria (Rotterdam phenotype A)

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Quality of Life
timeFrame: january 9th 2018-january 9th 2019
Secondary outcomes:
measure: Sexuality
timeFrame: january 9th 2018-january 9th 2019
measure: Psychological distress
timeFrame: january 9th 2018-january 9th 2019
measure: Anger and aggressiveness
timeFrame: january 9th 2018-january 9th 2019
Other outcomes:
measure: Biochemical markers
timeFrame: january 9th 2018-january 9th 2019
measure: Phenotipical traits
timeFrame: january 9th 2018-january 9th 2019
Locations:
city: Barcelona
country: Spain
facility: Hospital Clínic
Study officials:
affiliation: Hospital Clínic. University of Barcelona
name: Camil Castelo-Branco, MD PhD
role: STUDY_DIRECTOR
References:
citation: Naumova I, Castelo-Branco C, Casals G. Psychological Issues and Sexual Function in Women with Different Infertility Causes: Focus on Polycystic Ovary Syndrome. Reprod Sci. 2021 Oct;28(10):2830-2838. doi: 10.1007/s43032-021-00546-x. Epub 2021 Mar 24.