NCT06442228

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 14, 2024

Completed
21 days until next milestone

First Posted

Study publicly available on registry

June 4, 2024

Completed
4 months until next milestone

Study Start

First participant enrolled

October 7, 2024

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 7, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 16, 2024

Completed
Last Updated

November 19, 2024

Status Verified

November 1, 2024

Enrollment Period

Same day

First QC Date

May 14, 2024

Last Update Submit

November 16, 2024

Conditions

Keywords

malepolycystic ovary syndromeinfertility

Outcome Measures

Primary Outcomes (1)

  • The results of male factors in male patients with first-degree female relatives who fulfill the diagnostic criteria for PCOS

    sperm count

    6 months

Study Arms (1)

study group

EXPERIMENTAL

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.

Diagnostic Test: spermiogram test

Interventions

spermiogram testDIAGNOSTIC_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.

study group

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)
  • Those with a history of vasectomy, cryptorchism, radiation history, chemotherapy, infections, sexual dysfunction and endocrine hypogonadism
  • Especially those with a history of finasteride and dutasteride drug use.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Etlik Zübeyde Hanım

Ankara, 06000, Turkey (Türkiye)

Location

Related Publications (3)

  • 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.

    PMID: 32681618BACKGROUND
  • 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.

  • 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.

MeSH Terms

Conditions

Polycystic Ovary SyndromeInfertility

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Study Officials

  • Yaprak Ustun

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

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof

Study Record Dates

First Submitted

May 14, 2024

First Posted

June 4, 2024

Study Start

October 7, 2024

Primary Completion

October 7, 2024

Study Completion

November 16, 2024

Last Updated

November 19, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations