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

NCT06428786 | Completed DMC

• 1 other identifier: 02/08 28.02.2024
• Study Type: observational
• Target: 176
• Locations: 1 country
• Sites: 1

Brief Summary

This study was planned to examine whether different phenotypes of PCOS have an effect on quality of life, depression inventory and sexual function.

Conditions

Polycystic Ovary; Depression; Sexual Dysfunction

Keywords

Female Sexual Function Index; phenotypes; polycystic ovary syndrome; The Beck Depression Inventory; Quality of life

Outcome Measures

Primary Outcomes (3)

• Effect of PCOS phenotypes on SF-36.

  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.

  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

  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

Study Arms (4)

Phenotype A

PHENOTYPE A: Hyperandrogenism + Ovulatory Dysfunction + Polycystic ovary morphology 44 participants

Other: Female Sexual Function Index

Phenotype B

PHENOTYPE B: Hyperandrogenism + Ovulatory Dysfunction 44 participants

Other: Female Sexual Function Index

Phenotype C

PHENOTYPE C: Hyperandrogenism + Polycystic ovary morphology 44 participants

Other: Female Sexual Function Index

Phenotype D

PHENOTYPE D: Ovulatory Dysfunction + Polycystic ovary morphology 44 participants

Other: Female Sexual Function Index

Interventions

Female Sexual Function Index OTHER

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.

Also known as: Beck Depression Inventory, Short Form 36

Phenotype A; Phenotype B; Phenotype C; Phenotype D

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Etlik Zübeyde Hanım

Ankara, 06000, Turkey (Türkiye)

Location

Related Publications (2)

• Tian X, Ruan X, Du J, Cheng J, Ju R, Mueck AO. Sexual function in Chinese women with different clinical phenotypes of polycystic ovary syndrome. Gynecol Endocrinol. 2023 Dec;39(1):2221736. doi: 10.1080/09513590.2023.2221736.

  PMID: 37302412 BACKGROUND

• Yilmaz M, Isaoglu U, Delibas IB, Kadanali S. Anthropometric, clinical and laboratory comparison of four phenotypes of polycystic ovary syndrome based on Rotterdam criteria. J Obstet Gynaecol Res. 2011 Aug;37(8):1020-6. doi: 10.1111/j.1447-0756.2010.01478.x. Epub 2011 Apr 12.

  PMID: 21481088 RESULT

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Depression; Sexual Dysfunction, Physiological

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; Behavioral Symptoms; Behavior

Study Officials

• Mujde Can Ibanoglu

  Ankara Etlik Zubeyde Hanım Women's Health Training and Research Hospital, Ankara, Turkey.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof

Study Record Dates

• First Submitted: May 18, 2024
• First Posted: May 24, 2024
• Study Start: September 25, 2024
• Primary Completion: October 7, 2024
• Study Completion: February 25, 2025
• Last Updated: February 26, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)