Polycystic Ovary SyndromePCOSNCT06442228
History of Polycystic Ovary Syndrome in First-degree Relatives
A study testing spermiogram test in people with Polycystic Ovary Syndrome, run by Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Polycystic Ovary Syndrome
- What is being tested?
- spermiogram test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 Oct 2024to 16 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the History of Polycystic Ovary Syndrome in First-degree Relatives of Male Partners of Couples Presenting for Infertility Treatment
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.
Read the 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.
- Conditions
- Polycystic Ovary Syndrome
- Being tested
- spermiogram test
- Keywords
- male, polycystic ovary syndrome, infertility
- Medical subject headings
- Polycystic Ovary Syndrome, Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: spermiogram test |
What is being measured
The primary outcome is the main question the study is designed to answer.
The results of male factors in male patients with first-degree female relatives who fulfill the diagnostic criteria for PCOS
sperm count
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2024
- Study start7 Oct 2024
- Primary completion7 Oct 2024
- Study completion16 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mujde Can Ibanoglu, Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital
- Investigators
- Yaprak Ustun, Study director, Ankara Etlik Zubeyde Hanım Women's Health Training and Research Hospital, Ankara, Turkey.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06442228
- Sponsor's protocol ID
- 2024/05
- Acronym
- PCOS
- Status last verified
- Nov 2024
- First submitted
- 14 May 2024
- Last updated
- 19 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32681618Cannarella 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.
PubMed 28711970Duskova 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.
PubMed 16752800
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the History of Polycystic Ovary Syndrome in First-degree Relatives of Male Partners of Couples Presenting for Infertility Treatment
- ClinicalTrials.gov ID
- NCT06442228
- Acronym / sponsor ID
- PCOS / 2024/05
- Conditions
- Polycystic Ovary Syndrome
- Keywords
- male, polycystic ovary syndrome, infertility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Etlik Zubeyde Hanım Women's Health Care, Training and Research HospitalUniversity, hospital or other
- Study start
- 7 Oct 2024 (actual)
- Primary completion
- 7 Oct 2024 (actual)
- Study completion
- 16 Nov 2024 (actual)
- First posted
- 4 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| study group | Experimental | Diagnostic Test: spermiogram testIndividuals 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (3 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| spermiogram testApproximately 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. | Diagnostic test | study group |
Primary outcome
The results of male factors in male patients with first-degree female relatives who fulfill the diagnostic criteria for PCOS
Time frame: 6 months
sperm count
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2024.
- Background: PubMed 32681618Di 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.
- Results publication: PubMed 28711970Cannarella 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.
- Results publication: PubMed 16752800Duskova 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yaprak Ustun study director
Ankara Etlik Zubeyde Hanım Women's Health Training and Research Hospital, Ankara, Turkey.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing spermiogram test in people with Polycystic Ovary Syndrome, run by Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The results of male factors in male patients with first-degree female relatives who fulfill the diagnostic criteria for PCOS (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06442228, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2024.