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Pregnancy Chances in Classic Galactosemia

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ClinicalTrials.gov Identifier: NCT02091128
Recruitment Status : Completed
First Posted : March 19, 2014
Last Update Posted : September 13, 2016
Sponsor:
Information provided by (Responsible Party):
Maastricht University Medical Center

Tracking Information
First Submitted Date March 13, 2014
First Posted Date March 19, 2014
Last Update Posted Date September 13, 2016
Study Start Date March 2014
Actual Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 17, 2014)
Pregnancy incidence despite POI diagnosis [ Time Frame: day 1 ]
Will be assessed during semi-standardized interview
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02091128 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: March 17, 2014)
  • 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 Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Pregnancy Chances in Classic Galactosemia
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 Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Academic hospital
Condition
  • Galactosemias
  • Primary Ovarian Insufficiency
Intervention Not Provided
Study Groups/Cohorts Females with classic galactosemia and POI
Publications * Gubbels CS, Land JA, Rubio-Gozalbo ME. Fertility and impact of pregnancies on the mother and child in classic galactosemia. Obstet Gynecol Surv. 2008 May;63(5):334-43. doi: 10.1097/OGX.0b013e31816ff6c5. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 12, 2016)
85
Original Estimated Enrollment
 (submitted: March 17, 2014)
150
Actual Study Completion Date September 2016
Actual Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Classic galactosemia diagnosed by GALT enzyme activity assay or GALT-gene mutation analysis
  • Eighteen years of age or older
  • Diagnosed with POI defined as symptoms of hypergonadotrophic hypogonadism measured by serum concentrations of FSH and estradiol
  • Capable of giving informed consent

Exclusion Criteria:

  • Any known congenital or acquired disease or disorder negatively affecting pubertal development and/or fertility.
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number NCT02091128
Other Study ID Numbers METC 13-4-127
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Maastricht University Medical Center
Study Sponsor Maastricht University Medical Center
Collaborators Not Provided
Investigators
Principal Investigator: M. Estela Rubio-Gozalbo, Dr Maastricht University Medical Center
PRS Account Maastricht University Medical Center
Verification Date September 2016