Clinical Trial: Pregnancy Chances in Classic Galactosemia

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Pregnancy Chances in Classic Galactosemia

Brief Summary: With this study, in which the incidence of pregnancy in classic galactosemia patients is studied, we aim to provide new insights to improve counselling. Our hypothesis is that the chance that a galactosemic woman with POI becomes pregnant is higher than the 5-10% that has been reported for women with POI due to other causes. Chance of spontaneous pregnancy will be evaluated through semi standardized interview in women with classic galactosemia aged 18 years or older. During the interview, questions will be asked regarding fertility and pregnancy.

Detailed Summary:
Sponsor: Maastricht University Medical Center

Current Primary Outcome: Pregnancy incidence despite POI diagnosis [ Time Frame: day 1 ]

Will be assessed during semi-standardized interview


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Whether women have tried to conceive [ Time Frame: day 1 ]
    Will be assessed during semi-standardized interview
  • Time to pregnancy (in case a participant has been pregnant) [ Time Frame: day 1 ]
    Will be assessed during semi-standardized interview
  • Menstrual history [ Time Frame: day 1 ]
    Will be assessed during semi-standardized interview
  • Hormonal replacement therapy usage [ Time Frame: day 1 ]
    Will be assessed during semi-standardized interview


Original Secondary Outcome: Same as current

Information By: Maastricht University Medical Center

Dates:
Date Received: March 13, 2014
Date Started: March 2014
Date Completion:
Last Updated: September 12, 2016
Last Verified: September 2016