The Effect of Polycystic Ovary Syndrome Phenotypes on Quality of Life and Sexual Function (PCOS)

February 25, 2025 updated by: Mujde Can Ibanoglu, Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital
This study was planned to examine whether different phenotypes of PCOS have an effect on quality of life, depression inventory and sexual function.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Polycystic ovary syndrome (PCOS) is the most common endocrinologic pathology in women of reproductive age. Although the prevalence varies according to race, ethnicity and geographical region, it averages between 5-10%. The so-called Rotterdam criteria are: 1. Oligo- and/or anovulation, 2. Clinical and/or biochemical signs of hyperandrogenism, 3. Polycystic ovarian morphology on ultrasound, 4. Other conditions causing or associated with androgen elevation must be ruled out before a diagnosis of PCOS is made. Treatment needs, types and options vary according to phenotypic characteristics. The OD+HA+PKOM phenotype is considered a complete (classic) phenotype according to the Rotterdam classification and has the highest rate. Other phenotypes according to the Rotterdam criteria can be OD+HA (non-PCO phenotype), HA+PKOM (ovulation phenotype) or OD+PKOM (non-HA phenotype). Clinical pictures (phenotype A: HA + OD + PCOM; phenotype B: HA + OD; phenotype C: HA + PCOM and phenotype D: OD + PCOM). According to the Rotterdam criteria, endocrine and metabolic abnormalities are lowest in the OD+PCOM group among these 4 different phenotypes. The prevalence and distribution characteristics of metabolic abnormalities (insulin resistance, metabolic disease pattern and glucose intolerance) did not differ significantly between the 4 groups. Therefore, metabolic abnormalities and distribution characteristics are not used to differentiate the different clinical PCOS phenotypes.

Studies have shown that the "classic" PCOS group (phenotypes A and B) is more strongly associated with marked menstrual irregularity, elevated insulin levels and risk of metabolic syndrome; body mass index and obesity compared to the non-classic or non-hyperandrogenic PCOS phenotypes (phenotypes C and D).

There are numerous studies on whether phenotypic differences are based on ethnicity. Studies have shown that African-American women and women of Hispanic origin are more prone to obesity and the development of metabolic syndrome, while Middle Eastern women and women of Mediterranean origin are more prone to hirsutism. PCOS symptoms such as clinical hyperandrogenism, anovulation and menstrual irregularities can lead to a reduced quality of life, depression, mood disorders and sexual dysfunction. The physical, emotional and environmental scores were significantly lower in Group A patients compared to the other PCOS groups and the control group. The Short Form 36 (SF 36), which has the characteristics of a general scale among quality of life scales and provides broad measurement, was developed and put into use by the Rand Corporation in 1992. The scale was designed to be short and easy to administer and has a wide range of applications. The main feature of the SF-36, whose psychometric properties and scope have been expanded, is that it is a self-report scale that includes items on physical functioning, social functioning, role limitations related to physical functioning, role limitations related to emotional problems, mental health, energy/vitality, pain, and general perception of health.

The relationship between the severity of depressive symptoms and the different PCOS phenotypes is controversial. The Beck Depression Inventory (BDI-II), developed by Dr. Aaron T. Beck, is a questionnaire with 21 multiple-choice questions that can be used to measure the severity of depression. Scores ≥17 indicate severe depression requiring treatment.The depression inventory scores were higher in PCOS patients with infertility problems. A study found that there was no difference in depression scores between infertile and fertile groups.

The Female Sexual Function Index (FSFI) inventory was used to assess sexual dysfunction in obese PCOS patients. The Female Sexual Function Index was developed in 2000 to assess sexual function in women. The scale consists of 19 items and has 6 sub-dimensions: Pleasure, Arousal, Lubrication, Orgasm, Satisfaction and Pain. The scale reflects women's sexual functioning in the past month by calculating 6 subgroup scores and the FSFI score. The FSFI score is calculated by adding the subgroup scores. The Female Sexual Function Index has proven to be a valid and reliable tool for measuring sexual function in Turkish women.

Based on this information, the aim of this study was to investigate whether different phenotypes of PCOS have an impact on quality of life, depression inventory and sexual function.

Study Type

Observational

Enrollment (Actual)

176

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey, 06000
        • Etlik Zübeyde Hanım

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Sexually active people who are cared for at the PCOS Clinic of Etlik Zübeyde Hanım Gynecology Training and Research Hospital form the study group.

The study involves 176 subjects who agreed to participate in the study and accepted the informed consent verbally and in writing.

The ESHRE/ASRM 2023 guidelines will be used as a basis and those who fulfill both criteria below will be included in the PCOS group:

  1. Oligo and/or anovulation*
  2. Clinical and/or biochemical hyperandrogenism
  3. Polycystic ovarian morphology or AMH elevation

Definition of the phenotype groups: PCOS has been categorized into 4 phenotypes:

Phenotype A: Hyperandrogenism + ovarian dysfunction + PCOM PHENOTYPE B: HA+OD PHENOTYPE C: HA+PCOM PHENOTYPE D: OD+PKOM were grouped as.

Description

Inclusion Criteria:

  • least 1 year after menarche
  • over 18 years old
  • Patients who have given verbal and written informed consent will be included.

Exclusion Criteria:

  • under 18 years of age
  • Endocrine disorders such as hyperprolactinemia, Cushing's syndrome, congenital adrenal hyperplasia, thyroid disorders
  • Neuromuscular, hepatic, pancreatic or gastrointestinal diseases
  • Users of hormone preparations such as antiandrogens, antidiabetics, glucocorticoids, insulin sensitizers, lipid regulators

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Phenotype A
PHENOTYPE A: Hyperandrogenism + Ovulatory Dysfunction + Polycystic ovary morphology 44 participants
Other: Female Sexual Function Index
As part of the study, data on the socio-demographic characteristics of the individuals is collected by means of personal interviews using a questionnaire. The results of laboratory tests required for the diagnosis of PCOS will be taken from hospital records. The Female Sexual Function Index (FSFI), the Beck Depression Inventory and the KF-36 quality of life assessment form will be completed in person and the total scores will be analyzed taking into account four different PCOS phenotypes.
Other Names:
  • Beck Depression Inventory
  • Short Form 36
Phenotype B
PHENOTYPE B: Hyperandrogenism + Ovulatory Dysfunction 44 participants
Other: Female Sexual Function Index
As part of the study, data on the socio-demographic characteristics of the individuals is collected by means of personal interviews using a questionnaire. The results of laboratory tests required for the diagnosis of PCOS will be taken from hospital records. The Female Sexual Function Index (FSFI), the Beck Depression Inventory and the KF-36 quality of life assessment form will be completed in person and the total scores will be analyzed taking into account four different PCOS phenotypes.
Other Names:
  • Beck Depression Inventory
  • Short Form 36
Phenotype C
PHENOTYPE C: Hyperandrogenism + Polycystic ovary morphology 44 participants
Other: Female Sexual Function Index
As part of the study, data on the socio-demographic characteristics of the individuals is collected by means of personal interviews using a questionnaire. The results of laboratory tests required for the diagnosis of PCOS will be taken from hospital records. The Female Sexual Function Index (FSFI), the Beck Depression Inventory and the KF-36 quality of life assessment form will be completed in person and the total scores will be analyzed taking into account four different PCOS phenotypes.
Other Names:
  • Beck Depression Inventory
  • Short Form 36
Phenotype D
PHENOTYPE D: Ovulatory Dysfunction + Polycystic ovary morphology 44 participants
Other: Female Sexual Function Index
As part of the study, data on the socio-demographic characteristics of the individuals is collected by means of personal interviews using a questionnaire. The results of laboratory tests required for the diagnosis of PCOS will be taken from hospital records. The Female Sexual Function Index (FSFI), the Beck Depression Inventory and the KF-36 quality of life assessment form will be completed in person and the total scores will be analyzed taking into account four different PCOS phenotypes.
Other Names:
  • Beck Depression Inventory
  • Short Form 36

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of PCOS phenotypes on SF-36.
Time Frame: 6 months
The aim of this study was to investigate whether different phenotypes of PCOS have an impact on quality of life, depression inventory and sexual function.
6 months
Effect of PCOS phenotypes on FSFI.
Time Frame: 6 months
The aim of this study was to investigate whether different phenotypes of PCOS have an impact on quality of life, depression inventory and sexual function.
6 months
Effect of PCOS phenotypes on Beck Deppression scale
Time Frame: 6 months
The aim of this study was to investigate whether different phenotypes of PCOS have an impact on quality of life, depression inventory and sexual function.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital

Investigators

  • Principal Investigator: Mujde Can Ibanoglu, Ankara Etlik Zubeyde Hanım Women's Health Training and Research Hospital, Ankara, Turkey.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 25, 2024

Primary Completion (Actual)

October 7, 2024

Study Completion (Actual)

February 25, 2025

Study Registration Dates

First Submitted

May 18, 2024

First Submitted That Met QC Criteria

May 22, 2024

First Posted (Actual)

May 24, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 25, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 02/08 28.02.2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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