Polycystic Ovary SyndromeNCT03306459
Psychological Traits, Sexuality and Quality of Life in Patients With Polycystic Ovary Syndrome
An observational study of Polycystic Ovary Syndrome, run by Hospital Clinic of Barcelona at 1 site in Spain.
Trial summary
A prospective assessment of psychological characteristics, quality of life and sexuality in naïve patients. Read more about this study
- Who is it for?
- Ages 16 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Polycystic Ovary Syndrome
- What is being tested?
- SF-36 (Short Form Health Survey)
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 9 Jan 2018to 31 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 50 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: The authors will select 30 PCOS patients who met the more strict and conservative Rotterdam diagnostic criteria (Rotterdam phenotype A)
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Camil Castelo-Branco contact
Spain1 site
Hospital Clínic
Barcelona, 08036
Camil Castelo-Branco, MD PhD, +342275436, ccastelo@clinic.cat
Juliia Naumova, MD
About this study
Official title: Hospital Clínic Barcelona
A prospective assessment of psychological characteristics, quality of life and sexuality in naïve patients.
Read the 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.
- Conditions
- Polycystic Ovary Syndrome
- Being tested
- SF-36 (Short Form Health Survey)
- Keywords
- PCOS, Quality of life, Sexuality, Psychological traits
- Medical subject headings
- Polycystic Ovary Syndrome, Sexuality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SF-36 (Short Form Health Survey)Diagnostic test
Also called Female Sexual Function Index; Symptom Checklist-90-R; State-Trait-Anger-Expression-Inventory
Symptom Checklist-90-Revision (SCL-90-R): self-report questionnaire of 90 items on a 5-point Likert scale clustered in 9 primary scales (somatization, obsessive-compulsive, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation and psychoticism).
State-Trait-Anger-Expression-Inventory, version 2 (STAXI-2): self-report questionnaire of 57-items on a 4-point scale distributed in different dimensions: State-Anger, Trait-Anger Expression Anger (in-out) and Anger Control (in-out) Short Form Health Survey (SF-36), an instrument composed by 8 subscales: Physical Functioning, Physical Role Function, Bodily Pain, General Health, Vitality, Social Functioning, Emotional Role Function and Mental Health.
Female Sexual Function Index (FSFI) a 19-item self-report measure of female sexual function providing scores on 6 domains (desire, arousal, lubrication, orgasm, satisfaction, pain) as well as a total score.
| Study group | Role | What they receive |
|---|---|---|
| 1/PCOS | 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 Receives: Diagnostic Test: SF-36 (Short Form Health Survey) | |
| 2/CONTROL | 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. Receives: Diagnostic Test: SF-36 (Short Form Health Survey) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life
results of SF-36
Measured: january 9th 2018-january 9th 2019
Secondary outcomes (3)
Sexuality
Results of FSFI
Measured: january 9th 2018-january 9th 2019
Psychological distress
Results of Symptom Checklist-90-Revision (SCL-90-R)
Measured: january 9th 2018-january 9th 2019
Anger and aggressiveness
results of State-Trait-Anger-Expression-Inventory, version 2 (STAXI-2)
Measured: january 9th 2018-january 9th 2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2017
- Study start9 Jan 2018 (estimated)
- Primary completion9 Jan 2019 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- More trials run by Hospital Clinic of BarcelonaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Camil Castelo-Branco, Hospital Clinic of Barcelona
- Investigators
- Camil Castelo-Branco, MD PhD, Study director, Hospital Clínic. University of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03306459
- Sponsor's protocol ID
- B/2017/0614
- Status last verified
- Oct 2017
- First submitted
- 5 Oct 2017
- Last updated
- 20 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33763818
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hospital Clínic Barcelona
- ClinicalTrials.gov ID
- NCT03306459
- Acronym / sponsor ID
- B/2017/0614
- Conditions
- Polycystic Ovary Syndrome
- Keywords
- PCOS, Quality of life, Sexuality, Psychological traits
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Study start
- 9 Jan 2018 (estimated)
- Primary completion
- 9 Jan 2019 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 11 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1/PCOS | – | Diagnostic Test: SF-36 (Short Form Health Survey)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 |
| 2/CONTROL | – | Diagnostic Test: SF-36 (Short Form Health Survey)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. |
Who may qualify
- Ages
- 16 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- The authors will select 30 PCOS patients who met the more strict and conservative Rotterdam diagnostic criteria (Rotterdam phenotype A)
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SF-36 (Short Form Health Survey)Also: Female Sexual Function Index; Symptom Checklist-90-R; State-Trait-Anger-Expression-InventorySymptom Checklist-90-Revision (SCL-90-R): self-report questionnaire of 90 items on a 5-point Likert scale clustered in 9 primary scales (somatization, obsessive-compulsive, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation and psychoticism). State-Trait-Anger-Expression-Inventory, version 2 (STAXI-2): self-report questionnaire of 57-items on a 4-point scale distributed in different dimensions: State-Anger, Trait-Anger Expression Anger (in-out) and Anger Control (in-out) Short Form Health Survey (SF-36), an instrument composed by 8 subscales: Physical Functioning, Physical Role Function, Bodily Pain, General Health, Vitality, Social Functioning, Emotional Role Function and Mental Health. Female Sexual Function Index (FSFI) a 19-item self-report measure of female sexual function providing scores on 6 domains (desire, arousal, lubrication, orgasm, satisfaction, pain) as well as a total score. | Diagnostic test | 1/PCOS, 2/CONTROL |
Primary outcome
Quality of Life
Time frame: january 9th 2018-january 9th 2019
results of SF-36
3 secondary outcomes
Sexuality
Time frame: january 9th 2018-january 9th 2019
Psychological distress
Time frame: january 9th 2018-january 9th 2019
Anger and aggressiveness
Time frame: january 9th 2018-january 9th 2019
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2017.
- Derived from this study: PubMed 33763818Naumova 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Camil Castelo-Branco contact
Camil Castelo-Branco, MD PhD study director
Hospital Clínic. University of Barcelona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Polycystic Ovary Syndrome, run by Hospital Clinic of Barcelona at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Camil Castelo-Branco, MD PhD (1679999037, ccastelo@clinic.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life (time frame: january 9th 2018-january 9th 2019). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03306459, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2017.