Chronic Liver Disease and CirrhosisNCT07268196
Impact of Liver Transplantation on Sexual Life and Function
An observational study of Chronic Liver Disease and Cirrhosis, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial summary
Liver Transplantation (LT) is a lifesaving intervention with around 90% of recipients currently surviving the first postoperative year and subsequent life expectancy now exceeding 20 years. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men only
- Conditions the study is for
- Chronic Liver Disease and Cirrhosis
- What is being tested?
- No Treatment
- How many people
- 100 participants
- Where
- 1 siteIndia
- Study dates
- 7 Dec 2025to 23 Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 60 years
- Men only
- No healthy volunteers
- Adult
Study population: Chronic Liver Disease patients awaiting elective transplantation and post liver transplant patients.
Who may be able to join
- Married male Patients.
- Decompensated Chronic Liver Disease awaiting elective liver transplantation.
- Post Liver Transplant patients with stable graft function.
Who cannot join
- Negative consent.
- Patients with ongoing medical and surgical issues (biliary complications, graft complication etc.).
- Acute on Chronic Liver Failure and Acute Liver Failure patients.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
India1 site, 1 recruiting
- Recruiting
ILBS
New Delhi, National Capital Territory of Delhi, 110070
Dr. Rajagopalan G, DNB, 8220408324, prash1108@gmail.com
About this study
Liver Transplantation (LT) is a lifesaving intervention with around 90% of recipients currently surviving the first postoperative year and subsequent life expectancy now exceeding 20 years. After the post-operative recovery period, however, LT recipients become more and more confronted with the challenges of re-engagement with life after transplantation, a need to reach a new stability, reestablish function in everyday life, reconnect with valued roles, regain independence, and resume work Sexual function is a very important parameter in the evaluation of Quality of Life (QoL), as it has been shown that sexual dysfunction in transplant patients is associated with increased depression and decreased QoL. There are several studies in the relevant literature supporting the recovery of sexual function in patients after liver transplantation. It has been found that recovery was observed in erectile dysfunction in male patients 6 months after liver transplantation.
Read the detailed description
Liver Transplantation (LT) is a lifesaving intervention with around 90% of recipients currently surviving the first postoperative year and subsequent life expectancy now exceeding 20 years. After the post-operative recovery period, however, LT recipients become more and more confronted with the challenges of re-engagement with life after transplantation, a need to reach a new stability, reestablish function in everyday life, reconnect with valued roles, regain independence, and resume work Sexual function is a very important parameter in the evaluation of Quality of Life (QoL), as it has been shown that sexual dysfunction in transplant patients is associated with increased depression and decreased QoL. There are several studies in the relevant literature supporting the recovery of sexual function in patients after liver transplantation. It has been found that recovery was observed in erectile dysfunction in male patients 6 months after LT
- Conditions
- Chronic Liver Disease and Cirrhosis
- Being tested
- No Treatment
- Medical subject headings
- Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No TreatmentOther
This is an Observational Study
| Study group | Role | What they receive |
|---|---|---|
| Chronic liver Disease | Chronic Liver disease patients undergoing elective liver transplantation Receives: Other: No Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of sexual function by questionnaire method
Arizona Sexual Experience Scale (ASEX) scores for sexual dysfunction, ASEX scores are 5 point questionnaire with scores given for each question from 1-6. Total scores More than or equal to 19 indicate sexual dysfunction (higher the scores greater the sexual dysfunction).
Measured: pre transplant, 3,6,12 months
Evaluation of erectile dysfunction using questionnaire method
International Index for Erectile Function - 5 (IIEF-5) scores for erectile dysfunction IIEF 5 scores are also a 5 point questionnaire with score ranging 0-6 for each question. Total scores less than 15 indicate mild to moderate erectile dusfunction and scores less than 11 indicate moderate erectile dysfunction (lower the scores higher the erectile dysfunction)
Measured: pre transplant, 3,6,12 months
Secondary outcomes (2)
Correlation between testosterone and Meld Na scores
Testosterone measured in ng/ml. Less than 2.84 ng/ml is considered as hypogonadism
Measured: pre transplant, 3,6,12 months
Sarcopenia implication in recovery of sexual function.
Sarcopenia measured by third lumbar vertebra Skeletal muscle index. Values less than 52 indicates sarcopenia
Measured: pre transplant, 3,6,12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2025
- Study start7 Dec 2025
- Primary completion23 Oct 2026 (estimated)
- Study completion23 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Liver Disease and CirrhosisStudies of the same condition, open and under way.
- More trials run by Institute of Liver and Biliary Sciences, IndiaThe 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 only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Liver and Biliary Sciences, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Prof. Dr. Viniyendra Pamecha, MS FEBS, Study director, ILBS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07268196
- Sponsor's protocol ID
- IEC/2024/110/MA03
- Status last verified
- Dec 2025
- First submitted
- 22 Nov 2025
- Last updated
- 31 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Liver Transplantation on Sexual Life and Function
- ClinicalTrials.gov ID
- NCT07268196
- Acronym / sponsor ID
- IEC/2024/110/MA03
- Conditions
- Chronic Liver Disease and Cirrhosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 7 Dec 2025 (actual)
- Primary completion
- 23 Oct 2026 (estimated)
- Study completion
- 23 Oct 2026 (estimated)
- First posted
- 5 Dec 2025 (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.
Liver Transplantation (LT) is a lifesaving intervention with around 90% of recipients currently surviving the first postoperative year and subsequent life expectancy now exceeding 20 years. After the post-operative recovery period, however, LT recipients become more and more confronted with the challenges of re-engagement with life after transplantation, a need to reach a new stability, reestablish function in everyday life, reconnect with valued roles, regain independence, and resume work Sexual function is a very important parameter in the evaluation of Quality of Life (QoL), as it has been shown that sexual dysfunction in transplant patients is associated with increased depression and decreased QoL. There are several studies in the relevant literature supporting the recovery of sexual function in patients after liver transplantation. It has been found that recovery was observed in erectile dysfunction in male patients 6 months after liver transplantation.
Detailed description
Liver Transplantation (LT) is a lifesaving intervention with around 90% of recipients currently surviving the first postoperative year and subsequent life expectancy now exceeding 20 years. After the post-operative recovery period, however, LT recipients become more and more confronted with the challenges of re-engagement with life after transplantation, a need to reach a new stability, reestablish function in everyday life, reconnect with valued roles, regain independence, and resume work Sexual function is a very important parameter in the evaluation of Quality of Life (QoL), as it has been shown that sexual dysfunction in transplant patients is associated with increased depression and decreased QoL. There are several studies in the relevant literature supporting the recovery of sexual function in patients after liver transplantation. It has been found that recovery was observed in erectile dysfunction in male patients 6 months after LT
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chronic liver Disease | – | Other: No TreatmentChronic Liver disease patients undergoing elective liver transplantation |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Chronic Liver Disease patients awaiting elective transplantation and post liver transplant patients.
Key inclusion criteria (3 listed)
- Married male Patients.
- Decompensated Chronic Liver Disease awaiting elective liver transplantation.
- Post Liver Transplant patients with stable graft function.
Key exclusion criteria (3 listed)
- Negative consent.
- Patients with ongoing medical and surgical issues (biliary complications, graft complication etc.).
- Acute on Chronic Liver Failure and Acute Liver Failure patients.
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 |
|---|---|---|
| No TreatmentThis is an Observational Study | Other | Chronic liver Disease |
Primary outcome
Evaluation of sexual function by questionnaire method
Time frame: pre transplant, 3,6,12 months
Arizona Sexual Experience Scale (ASEX) scores for sexual dysfunction, ASEX scores are 5 point questionnaire with scores given for each question from 1-6. Total scores More than or equal to 19 indicate sexual dysfunction (higher the scores greater the sexual dysfunction).
Evaluation of erectile dysfunction using questionnaire method
Time frame: pre transplant, 3,6,12 months
International Index for Erectile Function - 5 (IIEF-5) scores for erectile dysfunction IIEF 5 scores are also a 5 point questionnaire with score ranging 0-6 for each question. Total scores less than 15 indicate mild to moderate erectile dusfunction and scores less than 11 indicate moderate erectile dysfunction (lower the scores higher the erectile dysfunction)
2 secondary outcomes
Correlation between testosterone and Meld Na scores
Time frame: pre transplant, 3,6,12 months
Sarcopenia implication in recovery of sexual function.
Time frame: pre transplant, 3,6,12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2025.
- Individual participant dataSharing planned: Undecided
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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.
Prof. Dr. Viniyendra Pamecha, MS FEBS study director
ILBS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Liver Disease and Cirrhosis, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
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 3 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: looking for participants now, as of the sponsor's last update on 31 Dec 2025. 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 India. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr. Rajagopalan G, DNB (8220408324, prash1108@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of sexual function by questionnaire method (time frame: pre transplant, 3,6,12 months). 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?
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 31 Dec 2025.