Male InfertilityNCT03167749
Effect of Liver Cirrhosis on Semen Parameters and Reproductive Hormones
An observational study of Male Infertility, run by Assiut University.
Trial summary
Normal testicular hormonal and spermatogenic function depends not only on the testis itself, but also on the integrity of the hypothalamus and anterior pituitary. Systemic diseases has been shown to influence male gonadal function in variety of ways, leading to reduced libido, erectile impotence, infertility… Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Male Infertility
- What is being tested?
- Laboratory test
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- Jan 2018to Mar 2019
- Phase
- Observational
- 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 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: male patients with liver cirrhosis will be recruited from the department of gastroenterology and tropical medicine and other group of healthy males without history or features of liver disease serves as the control group will be recruited from the outpatient clinics at Assiut university hospital.
Who may be able to join
- male patient with liver cirrhosis of any etiology and severity.
Who cannot join
- Systemic conditions like:chronic renal failure, diabetes mellitus, thyrotoxicosis, hypothyroidism, Cushing's disease and cancer.
- Local conditions like :Varicocele, urogenital infections, history of cryptorchidism, functional and obstructive azoospermia.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect of Type and Severity of Liver Cirrhosis on Semen Parameters and Reproductive Hormones
Normal testicular hormonal and spermatogenic function depends not only on the testis itself, but also on the integrity of the hypothalamus and anterior pituitary. Systemic diseases has been shown to influence male gonadal function in variety of ways, leading to reduced libido, erectile impotence, infertility, osteoporosis, and decreased physical stamina and muscle mass. The effect of systemic diseases may occur directly at the testicular level: reduced Leydig cell function will lead to androgen deficiency, while diseases affecting Spermatogenesis may lead to infertility. Alternatively, acute and chronic illness may interfere with the hypothalamic-pituitary axis and lead to reduced testicular function.
Read the detailed description
Liver is thoroughly involved in proteins, cytokines and interleukins synthesis and destruction. Therefore, abnormal function of endocrine organs is expected in patients with liver cirrhosis.
Hypogonadism is a frequent clinical feature in patients with liver cirrhosis. These patients have gynecomastia, decreased libido, signs of feminization, testicular atrophy and low testosterone level, as well as reduced Spermatogenesis. These features are more severe in patients with higher Child Pugh score.
Several hormonal abnormalities are responsible for these clinical alterations. Estrogen/androgen ratio has been increased in cirrhosis while there is reduction in serum testosterone and dehydroepiandrosterone level.
Hyperprolactinemia is present in patients with cirrhosis and may involve in Hypogonadism by an inhibitory effect on gonadotropins.
- Conditions
- Male Infertility
- Being tested
- Laboratory test
- Medical subject headings
- Infertility, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laboratory testDiagnostic test
Semen analysis and reproductive hormonal assay (free and total testosterone, luteinizing hormone, follicle-stimulating hormone , estradiol and prolactin hormone) for both patients and control group
| Study group | Role | What they receive |
|---|---|---|
| Patients group | Male patients with liver cirrhosis of any etiology and severity. Laboratory tests will be done Receives: Diagnostic Test: Laboratory test | |
| Control group | Healthy males without history or features of liver disease. Laboratory tests will be done Receives: Diagnostic Test: Laboratory test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Semen parameters (volume, total sperm count and sperm concentration, motility and morphology)
Mean difference in semen parameters(volume, total sperm count and sperm concentration, motility and morphology) between patients and control group
Measured: Baseline
Serum level of reproductive hormones (free and total testosterone, luteinizing hormone , follicle-stimulating hormone, estradiol and prolactin hormone)
Mean difference in serum level of reproductive hormones(free and total testosterone, luteinizing hormone, follicle-stimulating hormone , estradiol and prolactin hormone) between patients and control group
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2017
- Study startJan 2018 (estimated)
- Primary completionJan 2019 (estimated)
- Study completionMar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Male InfertilityStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Allam, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03167749
- Sponsor's protocol ID
- LcRh
- Status last verified
- May 2017
- First submitted
- 23 May 2017
- Last updated
- 30 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Turner HE, Wass JA. Gonadal function in men with chronic illness. Clin Endocrinol (Oxf). 1997 Oct;47(4):379-403. doi: 10.1046/j.1365-2265.1997.2611108.x. No abstract available.
PubMed 9404435Eshraghian A, Taghavi SA. Systematic review: endocrine abnormalities in patients with liver cirrhosis. Arch Iran Med. 2014 Oct;17(10):713-21.
PubMed 25305772Karagiannis A, Harsoulis F. Gonadal dysfunction in systemic diseases. Eur J Endocrinol. 2005 Apr;152(4):501-13. doi: 10.1530/eje.1.01886.
PubMed 15817904van Thiel DH, Gavaler JS, Spero JA, Egler KM, Wright C, Sanghvi AT, Hasiba U, Lewis JH. Patterns of hypothalamic-pituitary-gonadal dysfunction in men with liver disease due to differing etiologies. Hepatology. 1981 Jan-Feb;1(1):39-46. doi: 10.1002/hep.1840010107.
PubMed 6793494Bannister P, Oakes J, Sheridan P, Losowsky MS. Sex hormone changes in chronic liver disease: a matched study of alcoholic versus non-alcoholic liver disease. Q J Med. 1987 Apr;63(240):305-13.
PubMed 2960998Simon-Holtorf J, Monig H, Klomp HJ, Reinecke-Luthge A, Folsch UR, Kloehn S. Expression and distribution of prolactin receptor in normal, fibrotic, and cirrhotic human liver. Exp Clin Endocrinol Diabetes. 2006 Nov;114(10):584-9. doi: 10.1055/s-2006-948310.
PubMed 17177141
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Type and Severity of Liver Cirrhosis on Semen Parameters and Reproductive Hormones
- ClinicalTrials.gov ID
- NCT03167749
- Acronym / sponsor ID
- LcRh
- Conditions
- Male Infertility
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jan 2018 (estimated)
- Primary completion
- Jan 2019 (estimated)
- Study completion
- Mar 2019 (estimated)
- First posted
- 30 May 2017 (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.
Normal testicular hormonal and spermatogenic function depends not only on the testis itself, but also on the integrity of the hypothalamus and anterior pituitary. Systemic diseases has been shown to influence male gonadal function in variety of ways, leading to reduced libido, erectile impotence, infertility, osteoporosis, and decreased physical stamina and muscle mass. The effect of systemic diseases may occur directly at the testicular level: reduced Leydig cell function will lead to androgen deficiency, while diseases affecting Spermatogenesis may lead to infertility. Alternatively, acute and chronic illness may interfere with the hypothalamic-pituitary axis and lead to reduced testicular function.
Detailed description
Liver is thoroughly involved in proteins, cytokines and interleukins synthesis and destruction. Therefore, abnormal function of endocrine organs is expected in patients with liver cirrhosis.
Hypogonadism is a frequent clinical feature in patients with liver cirrhosis. These patients have gynecomastia, decreased libido, signs of feminization, testicular atrophy and low testosterone level, as well as reduced Spermatogenesis. These features are more severe in patients with higher Child Pugh score.
Several hormonal abnormalities are responsible for these clinical alterations. Estrogen/androgen ratio has been increased in cirrhosis while there is reduction in serum testosterone and dehydroepiandrosterone level.
Hyperprolactinemia is present in patients with cirrhosis and may involve in Hypogonadism by an inhibitory effect on gonadotropins.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients group | – | Diagnostic Test: Laboratory testMale patients with liver cirrhosis of any etiology and severity. Laboratory tests will be done |
| Control group | – | Diagnostic Test: Laboratory testHealthy males without history or features of liver disease. Laboratory tests will be done |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- male patients with liver cirrhosis will be recruited from the department of gastroenterology and tropical medicine and other group of healthy males without history or features of liver disease serves as the control group will be recruited from the outpatient clinics at Assiut university hospital.
Key inclusion criteria (1 listed)
- male patient with liver cirrhosis of any etiology and severity.
Key exclusion criteria (2 listed)
- Systemic conditions like:chronic renal failure, diabetes mellitus, thyrotoxicosis, hypothyroidism, Cushing's disease and cancer.
- Local conditions like :Varicocele, urogenital infections, history of cryptorchidism, functional and obstructive azoospermia.
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 |
|---|---|---|
| Laboratory testSemen analysis and reproductive hormonal assay (free and total testosterone, luteinizing hormone, follicle-stimulating hormone , estradiol and prolactin hormone) for both patients and control group | Diagnostic test | Control group, Patients group |
Primary outcome
Semen parameters (volume, total sperm count and sperm concentration, motility and morphology)
Time frame: Baseline
Mean difference in semen parameters(volume, total sperm count and sperm concentration, motility and morphology) between patients and control group
Serum level of reproductive hormones (free and total testosterone, luteinizing hormone , follicle-stimulating hormone, estradiol and prolactin hormone)
Time frame: Baseline
Mean difference in serum level of reproductive hormones(free and total testosterone, luteinizing hormone, follicle-stimulating hormone , estradiol and prolactin hormone) between patients and control group
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2017.
- Background: PubMed 9404435Turner HE, Wass JA. Gonadal function in men with chronic illness. Clin Endocrinol (Oxf). 1997 Oct;47(4):379-403. doi: 10.1046/j.1365-2265.1997.2611108.x. No abstract available.
- Background: PubMed 25305772Eshraghian A, Taghavi SA. Systematic review: endocrine abnormalities in patients with liver cirrhosis. Arch Iran Med. 2014 Oct;17(10):713-21.
- Background: PubMed 15817904Karagiannis A, Harsoulis F. Gonadal dysfunction in systemic diseases. Eur J Endocrinol. 2005 Apr;152(4):501-13. doi: 10.1530/eje.1.01886.
- Background: PubMed 6793494van Thiel DH, Gavaler JS, Spero JA, Egler KM, Wright C, Sanghvi AT, Hasiba U, Lewis JH. Patterns of hypothalamic-pituitary-gonadal dysfunction in men with liver disease due to differing etiologies. Hepatology. 1981 Jan-Feb;1(1):39-46. doi: 10.1002/hep.1840010107.
- Background: PubMed 2960998Bannister P, Oakes J, Sheridan P, Losowsky MS. Sex hormone changes in chronic liver disease: a matched study of alcoholic versus non-alcoholic liver disease. Q J Med. 1987 Apr;63(240):305-13.
- Background: PubMed 17177141Simon-Holtorf J, Monig H, Klomp HJ, Reinecke-Luthge A, Folsch UR, Kloehn S. Expression and distribution of prolactin receptor in normal, fibrotic, and cirrhotic human liver. Exp Clin Endocrinol Diabetes. 2006 Nov;114(10):584-9. doi: 10.1055/s-2006-948310.
- Individual participant dataSharing planned: No
Related trials for Male Infertility
Active, not recruitingObservational study
Retrieval of Sperm From Men With Azoospermia Using Ultrasound-guided Rete Testis Aspiration
Azoospermia, Nonobstructive, Infertility, Male
Not yet recruitingPhase 3
Comparative Study of Post-Varicocelectomy Myo-inositol vs. Antioxidants vs. Surgery Alone in Infertile Men
Myo-inositol, Post Varicocelectomy
Not yet recruitingPhase 2
PRECISION-E2: Teverelix in Women With Endometriosis - Pharmacodynamics, Safety and Precision Medicine Correlates
Endometriosis Pelvic, Endometriosis Ovaries
Not yet recruiting
Sperm, Exposure and Endocrine Disruptors
Fertility, Male Fertility
RecruitingObservational study
Inherited Reproductive Disorders
Genetic Disorder, Infertility
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Male Infertility, run by Assiut University.
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 2 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: status not confirmed, as of the sponsor's last update on 30 May 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dr Emad_eldin Kamal (00201004026100, emad@fertility-eg.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Semen parameters (volume, total sperm count and sperm concentration, motility and morphology) (time frame: Baseline). The study lists 2 primary outcomes in all. 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 NCT03167749, which also lists 6 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 30 May 2017.