History of Polycystic Ovary Syndrome in First-degree Relatives

NCT ID: NCT06442228

Last Updated: 2024-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-07

Study Completion Date

2024-11-16

Brief Summary

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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

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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.

Conditions

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Polycystic Ovary Syndrome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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study group

Individuals who have undergone spermiogram analysis at Etlik Zübeyde Hanım Gynecology Training and Research Hospital and whose first-degree relatives have a family history of PCOS will be included in the study group. Individuals who have undergone a spermiogram in our hospital, who fulfill the inclusion criteria and who do not have a family history of PCOS will be studied as a control group.

Group Type EXPERIMENTAL

spermiogram test

Intervention Type DIAGNOSTIC_TEST

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.

Interventions

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spermiogram test

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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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Mujde Can Ibanoglu

Assoc. Prof

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yaprak Ustun

Role: STUDY_DIRECTOR

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

Locations

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Etlik Zübeyde Hanım

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Di Guardo F, Ciotta L, Monteleone M, Palumbo M. Male Equivalent Polycystic Ovarian Syndrome: Hormonal, Metabolic, and Clinical Aspects. Int J Fertil Steril. 2020 Jul;14(2):79-83. doi: 10.22074/ijfs.2020.6092. Epub 2020 Jul 15.

Reference Type BACKGROUND
PMID: 32681618 (View on PubMed)

Cannarella R, Condorelli RA, Mongioi LM, La Vignera S, Calogero AE. Does a male polycystic ovarian syndrome equivalent exist? J Endocrinol Invest. 2018 Jan;41(1):49-57. doi: 10.1007/s40618-017-0728-5. Epub 2017 Jul 15.

Reference Type RESULT
PMID: 28711970 (View on PubMed)

Duskova M, Starka L. The existence of a male equivalent of the polycystic ovary syndrome--the present state of the issue. Prague Med Rep. 2006;107(1):17-25.

Reference Type RESULT
PMID: 16752800 (View on PubMed)

Other Identifiers

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2024/05

Identifier Type: -

Identifier Source: org_study_id

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