Impact of Liver Transplantation on Sexual Life and Function

NCT07268196 | Recruiting

• 1 other identifier: IEC/2024/110/MA03
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Chronic Liver Disease and Cirrhosis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Correlation between testosterone and Meld Na scores

  pre transplant, 3,6,12 months

• Sarcopenia implication in recovery of sexual function.

  pre transplant, 3,6,12 months

Study Arms (1)

Chronic liver Disease

Chronic Liver disease patients undergoing elective liver transplantation

Other: No Treatment

Interventions

No Treatment OTHER

This is an Observational Study

Chronic liver Disease

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

ILBS

New Delhi, National Capital Territory of Delhi, 110070, India

RECRUITING

MeSH Terms

Conditions

Fibrosis

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Prof. Dr. Viniyendra Pamecha, MS FEBS

  ILBS

  STUDY DIRECTOR

Central Study Contacts

Dr. Rajagopalan G, DNB

CONTACT

8220408324; prash1108@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2025
• First Posted: December 5, 2025
• Study Start: December 7, 2025
• Primary Completion (Estimated): October 23, 2026
• Study Completion (Estimated): October 23, 2026
• Last Updated: December 31, 2025

Record last verified: 2025-12

Locations

IN (1)