History of Polycystic Ovary Syndrome in First-degree Relatives
PCOS
Investigation of the History of Polycystic Ovary Syndrome in First-degree Relatives of Male Partners of Couples Presenting for Infertility Treatment
1 other identifier
interventional
50
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2024
Shorter than P25 for not_applicable
1 active site
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
CompletedFirst Posted
Study publicly available on registry
June 4, 2024
CompletedStudy Start
First participant enrolled
October 7, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 7, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
November 16, 2024
CompletedNovember 19, 2024
November 1, 2024
Same day
May 14, 2024
November 16, 2024
Conditions
Keywords
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
EXPERIMENTALIndividuals 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.
Interventions
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.
Eligibility Criteria
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)
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: 32681618BACKGROUNDCannarella 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.
PMID: 28711970RESULTDuskova 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.
PMID: 16752800RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Yaprak Ustun
Ankara Etlik Zubeyde Hanım Women's Health Training and Research Hospital, Ankara, Turkey.
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