History of Polycystic Ovary Syndrome in First-degree Relatives

Trial Title: History of Polycystic Ovary Syndrome in First-degree Relatives

NCT ID: NCT06442228

Condition: Polycystic Ovary Syndrome

Conditions: Official terms:
Polycystic Ovary Syndrome
Syndrome

Conditions: Keywords:
male
polycystic ovary syndrome
infertility

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Screening

Masking: None (Open Label)

Intervention:

Intervention type: Diagnostic Test
Intervention name: spermiogram test
Description: Approximately 7 mL of blood sample will be taken by the health personnel in a vacuum gel tube for hormonal and biochemical analyses. The blood samples will be centrifuged at 1000xg for 20 minutes by the researchers. In the next step, the supernatant portion will be separated and transferred to 3 mL ependorfs. Serum samples will be stored in the -800C deep freezer of our hospital until the time of analysis. Sperm samples from individuals will be collected in our hospital in accordance with the protocol and the results will be reported.
Arm group label: study group

Summary: The aim of this study was to investigate the semen analysis results of male patients with first-degree relatives meeting the diagnostic criteria for PCOS.

Detailed description: Polycystic ovary syndrome (PCOS) is an endocrine metabolic disorder characterised by menstrual irregularity, anovulation, clinical and/or biochemical signs of hyper androgenism (hirsutism and/or acne), micropolycystic ovaries and metabolic abnormalities. This syndrome is clustered in family members and appears to be inherited through an oligogenic mechanism (1,2). As a result of familial clustering of the PCOS phenotype, metabolic risks have been shown to increase in family members, independent of gender. The presence of a genetic background in the etiopathogenesis of PCOS means that men may also have signs and symptoms equivalent to PCOS. In addition, the genes responsible for PCOS susceptibility in women are also transferred to male relatives of these individuals. Hormonal and metabolic abnormalities have been identified in male relatives of women with PCOS. These men have shown a higher prevalence of early-onset (<35 years) androgenetic alopecia (AGA), type 2 DM and cardivascular diseases. In addition, prostate cancer, benign prostatic hyperplasia (BPH) and prostatitis have also been defined more frequently in this group of individuals (1,3). In addition, differences in responses to gonadotropin-releasing hormone (GnRH) and FSH and LH levels were found in the brothers of women with PCOS compared to control groups. According to genome studies (GWAS), FSHB gene on chromosome 11p14.1 represents the PCOS susceptibility focus in women (1). Genetic variations in FSHB affect male reproductive function. In fact, polymorphisms of the FSHB promoter have been associated with lower sperm count, higher LH, lower FSH and lower testicular volume (3,4). In the light of this information, in this study, it was planned to evaluate the comparison of semen analysis results of male patients with a first-degree relative diagnosed with PCOS with the control group.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - The study will include male partners between the ages of 18-40 who have no known disease, who give spermiogram test for the evaluation of infertile couple in our hospital and who have accepted the consent form verbally and in writing. Exclusion Criteria: - Exclusion criteria; 1. History of any chronic disease, urinary tract or reproductive disease, neurological or psychiatric condition in the male patient and recent fever (≥38°C in the last 3 months) 2. Those with a history of vasectomy, cryptorchism, radiation history, chemotherapy, infections, sexual dysfunction and endocrine hypogonadism 3. Especially those with a history of finasteride and dutasteride drug use.

Gender: All

Minimum age: 18 Years

Maximum age: 40 Years

Healthy volunteers: Accepts Healthy Volunteers

Locations:

Facility:
Name: Etlik Zübeyde Hanım

Address:
City: Ankara
Zip: 06000
Country: Turkey

Status: Recruiting

Contact:
Last name: Mujde Can Ibanoglu
Email: Drmujdecan@gmail.com

Start date: October 7, 2024

Completion date: October 7, 2024

Lead sponsor:
Agency: Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital
Agency class: Other

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

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06442228