PIP-C Study

Paternally Inherited Phenotypes in Cholestasis Study - (PIP-C)

ClinicalTrials.gov Identifier NCT03337074

This study is investigating whether cholestatic liver diseases such as PSC can impact the structure and function of sperm. This is important because changes to the sperm can affect the health of the children conceived from those sperm. In this study, the health of 16 – 25 year-old children of fathers with cholestatic liver diseases such as PSC is also being investigated.

The study has 2 arms, the Sperm Epigenome arm and the Outcomes arm. Each participant can decide if they are eligible/would like to take part in one or in both arms of the study.

  • In the Sperm Epigenome arm, the structure and function of sperm from men with PSC and other cholestatic liver disorders will be investigated and compared to the structure and function of sperm from healthy men.
  • In the Outcomes arm, basic health parameters in fathers who had PSC or another cholestatic liver disease either before or after their child was conceived will be investigated, as well as basic health parameters in their child when they are aged between 16 and 25 years old.

UK Study Locations

Liver Unit
King's College Hospital
Denmark Hill
London
SE5 9RS

Assisted Conception Unit
Guy's Hospital NHS Foundation Trust
Great Maze Pond
London
SE1 9RT

Queen Elizabeth Hospital
Mindelsohn Way
Birmingham
B15 2TH

Contact information

Chief Investigator: Professor Catherine Williamson (catherine.williamson@kcl.ac.uk)

Investigator: Saraid McIlvride (saraid.a.mcilvride@kcl.ac.uk)

Eligibility

Sperm Epigenome Arm

Men over 18 years of age who:

  • Have a diagnosis of a cholestatic liver disorder including but not restricted to PSC.
  • Are able and willing to give informed consent.
  • Do not have a history of diabetes or obesity.
  • Do not have gallstones, cancer or other acute cholestatic pathology.
  • Do not have a history of alcohol excess or drug abuse.
  • Do not smoke.
  • Do not have HIV or hepatitis B or C.

Outcomes Arm

Fathers who:

  • Have a diagnosis of a cholestatic liver disorder including but not restricted to PSC.
  • Have children aged between 16 - 25 years of age.
  • Are able and willing to give informed consent.

Children of men with PSC or other cholestatic liver disorders who:

  • Are aged between 16 – 25 years of age.
  • Were born from an uncomplicated singleton pregnancy.
  • Are able and willing to give informed consent.

Download the Patient Information Sheets

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