Effect of Liver Cirrhosis on Semen Parameters and Reproductive Hormones
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ClinicalTrials.gov Identifier: NCT03167749 |
Recruitment Status : Unknown
Verified May 2017 by Mohamed Allam, Assiut University.
Recruitment status was: Not yet recruiting
First Posted : May 30, 2017
Last Update Posted : May 30, 2017
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Condition or disease | Intervention/treatment |
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Male Infertility | Diagnostic Test: Laboratory test |
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 Type : | Observational |
Estimated Enrollment : | 90 participants |
Observational Model: | Case-Control |
Time Perspective: | Cross-Sectional |
Official Title: | Effect of Type and Severity of Liver Cirrhosis on Semen Parameters and Reproductive Hormones |
Estimated Study Start Date : | January 2018 |
Estimated Primary Completion Date : | January 2019 |
Estimated Study Completion Date : | March 2019 |

Group/Cohort | Intervention/treatment |
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Patients group
Male patients with liver cirrhosis of any etiology and severity. Laboratory tests will be done
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Diagnostic Test: Laboratory 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 |
Control group
Healthy males without history or features of liver disease. Laboratory tests will be done
|
Diagnostic Test: Laboratory 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 |
- 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

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Probability Sample |
Inclusion Criteria:
- male patient with liver cirrhosis of any etiology and severity.
Exclusion Criteria:
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03167749
Contact: Dr Emad_eldin Kamal | 00201004026100 | emad@fertility-eg.com | |
Contact: Dr Ahmad Abdel_mageed | 00201001349280 | Dr_ahmed1978@yahoo.com |
Responsible Party: | Mohamed Allam, Principal investigator, Assiut University |
ClinicalTrials.gov Identifier: | NCT03167749 |
Other Study ID Numbers: |
LcRh |
First Posted: | May 30, 2017 Key Record Dates |
Last Update Posted: | May 30, 2017 |
Last Verified: | May 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Liver Cirrhosis Infertility Infertility, Male Liver Diseases Digestive System Diseases |