Impact of Liver Transplantation on Sexual Life and Function

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Liver Disease and Cirrhosis
• Intervention / Treatment: Other: No Treatment

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 Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Dr. Rajagopalan G, DNB; Phone Number: 8220408324; Email: prash1108@gmail.com

Study Locations

• India
  • National Capital Territory of Delhi
    • New Delhi, National Capital Territory of Delhi, India, 110070
      • Recruiting
      • ILBS
      • Contact: Dr. Rajagopalan G, DNB; Phone Number: 8220408324; Email: prash1108@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Chronic Liver Disease patients awaiting elective transplantation and post liver transplant patients.

Description

Inclusion Criteria:

1. Married male Patients.
2. Decompensated Chronic Liver Disease awaiting elective liver transplantation.
3. Post Liver Transplant patients with stable graft function.

Exclusion Criteria:

1. Negative consent.
2. Patients with ongoing medical and surgical issues (biliary complications, graft complication etc.).
3. Acute on Chronic Liver Failure and Acute Liver Failure patients.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Chronic liver Disease; Chronic Liver disease patients undergoing elective liver transplantation	Other: No Treatment; This is an Observational Study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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)	pre transplant, 3,6,12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between testosterone and Meld Na scores	Testosterone measured in ng/ml. Less than 2.84 ng/ml is considered as hypogonadism	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	pre transplant, 3,6,12 months

Collaborators and Investigators

• Sponsor: Institute of Liver and Biliary Sciences, India
• Investigators: Study Director: Prof. Dr. Viniyendra Pamecha, MS FEBS, ILBS

Study record dates

Study Major Dates

• Study Start (Actual): December 7, 2025
• Primary Completion (Estimated): October 23, 2026
• Study Completion (Estimated): October 23, 2026

Study Registration Dates

• First Submitted: November 22, 2025
• First Submitted That Met QC Criteria: December 3, 2025
• First Posted (Estimated): December 5, 2025

Study Record Updates

• Last Update Posted (Actual): December 31, 2025
• Last Update Submitted That Met QC Criteria: December 24, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Pathological Conditions, Signs and Symptoms; Fibrosis
• Other Study ID Numbers: IEC/2024/110/MA03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No