Clinical trial · Observational
Psychological Traits, Sexuality and Quality of Life in Patients With Polycystic Ovary Syndrome
Hospital Clínic Barcelona
NCT03306459CI-TRIAL-00029990unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
A prospective assessment of psychological characteristics, quality of life and sexuality in naïve patients.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Polycystic Ovary Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SF-36 (Short Form Health Survey) | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- 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
- interventionNames
- Diagnostic Test: SF-36 (Short Form Health Survey)
- label
- 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.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 16 Years
- Maximum age
- 50 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDNaumova 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. PMID 33763818