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COPENHAGEN Minipuberty Study (CPHMINIPUB)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02784184
Recruitment Status : Active, not recruiting
First Posted : May 27, 2016
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Anders Juul, Rigshospitalet, Denmark

Brief Summary:

Minipuberty is a term used to describe the transient activation of the pituitary-gonadal axis 2-3 months after birth in both boys and girls. It is, however, not known why infants reach adult levels of reproductive hormones in early life, nor is the exact timing of the peak known. Furthermore, what determines the timing of peaks and suppressions of reproductive hormones from infancy throughout childhood and into adolescence remains to be elucidated.

The study aims to described and evaluate dynamic changes in the hypothalamic-pituitary- gonadal axis in early postnatal life.


Condition or disease
Child Development Disorders of Sex Development

Show Show detailed description

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Study Type : Observational
Estimated Enrollment : 280 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: COPENHAGEN Minipuberty Study
Study Start Date : August 2016
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Group/Cohort
1 year follow-up group
1 year follow-up group including 6 measurements
40 days diaper study subgroup
Subgroup of the "1 year follow-up group" including 15 girls undergoing daily measurement of urinary hormone excretion



Primary Outcome Measures :
  1. Serum and urinary metabolites of reproductive hormones (e.g. steroid hormone metabolites and gonadotropins) (newborn) [ Time Frame: 3-7d, and 1,3,5,7,12m or 2,4,6,8,12m after birth plus 40 days daily measurement (urine, female 40 days diaper study subgroup) ]
    change/course serum and urinary metabolites

  2. Urinary metabolites of endocrine disrupting chemicals (e.g. phthalates, phenols, perfluorinated compounds and parabens) (newborn) [ Time Frame: 3-7d, & 1,3,5,7,12m or 2,4,6,8,12m after birth plus 40 days daily measurement (urine, female 40 days diaper study subgroup) ]
    change/course urinary metabolites

  3. Basic clinical examination (newborn) (size and proportions) [ Time Frame: 3-7d, and 1,3,5,7,12m or 2,4,6,8,12m after birth ]
    change/course: measurements of length, weight, skin folds and hip-waist ratio

  4. Basic clinical examination (newborn) (pubertal staging) [ Time Frame: 3-7d, and 1,3,5,7,12m or 2,4,6,8,12m after birth ]
    change/course: pubertal staging using Tanners classification (including testicular size in boys assessed by Prader's orchidometer and ultrasound

  5. Basic clinical examination (newborn) (genitalia) [ Time Frame: 3-7d, and 1,3,5,7,12m or 2,4,6,8,12m after birth ]
    change/course: classification of external genitalia (classification of genital tubercle, location of gonads, position of urethra, labia/scrotal fusion)

  6. Basic clinical examination (newborn) (penile measurement) [ Time Frame: 3-7d, and 1,3,5,7,12m or 2,4,6,8,12m after birth ]
    change/course: penile measurement with a ruler (in boys)

  7. Basic clinical examination (newborn) (AGD) [ Time Frame: 3-7d, and 1,3,5,7,12m or 2,4,6,8,12m after birth ]
    change/course: ano-genital distance (AGD) measured with a ruler

  8. Genetic profiling [ Time Frame: single determination or 3-7d, and 1,3,5,7,12m or 2,4,6,8,12m after birth ]
    Genotyping of different genetic loci (genetic variation of loci regulating hormone signalling, e.g. FSHB, etc.)

  9. Epigenetic profiling [ Time Frame: single determination or 3-7d, and 1,3,5,7,12m or 2,4,6,8,12m after birth ]
    change/course: epigenetic variation of loci regulating hormone signalling


Secondary Outcome Measures :
  1. Basic clinical examination (parents) (height) [ Time Frame: postpartal (within first 3 months) ]
    Height

  2. Basic clinical examination (parents) (weight) [ Time Frame: postpartal (within first 3 months) ]
    self-reported pre-pregnancy weight for the mother and postpartal weight of the father

  3. Basic clinical examination (parents) [ Time Frame: postpartal (within first 3 months) ]
    Skinfolds measured above the biceps, triceps, at the flank, and below the scapula

  4. Pregnancy and perinatal outcome (newborn and mother) [ Time Frame: before birth and perinatal phase ]
    Perinatal outcome including birth weight, -length, partus mode, adverse events/complications, pre- and perinatal drug intake, pregnancy outcomes including gestational age, pregnancy complications, IVF Treatment etc.

  5. Medical history and exposure (parents) (basic) [ Time Frame: postpartal (within first year) ]
    Basic medical history (parents) (questionaire / journal)

  6. Medical history and exposure (parents) (obstetrical) [ Time Frame: postpartal (within first year) ]
    Obstetrical history including outcomes of previous pregnancies and births (mother), smoking and drug intake during pregnancy (mother) (questionaire / journal)

  7. Medical history and exposure (parents) (puberty) [ Time Frame: postpartal (within first year) ]
    Pubertal history (parents) including age at menarche, pubertal timing with regard to peers, age at menopause of the mother of the parents etc. (questionaire)

  8. Breastfeeding and food intake (newborn) [ Time Frame: first year of life ]
    change/course: breastfeeding and food intake of the newborn during the course of the first year (questionaire)


Biospecimen Retention:   Samples With DNA
DNA EDTA-Blood Serum


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 12 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Pregnant women, meeting the inclusion criteria, and the fathers-to-be followed at the Department of Obstetrics, Rigshospitalet. Further, parents and infants with disordered sexual development (DSD). These patients will be recruited via The Department of Growth and Reproduction, Rigshospitalet. Parents whose fetuses have been diagnosed prenatally with any DSD diagnosis or during the first 6 months of life will be invited to participate.

Three groups of participants in this study:

  1. A group of healthy infants
  2. All infant patients diagnosed with or under evaluation for DSD
  3. The parents of the healthy infants and DSD patients

Number (approximately) of participants:

  1. 200 healthy infants (100 boys and 100 girls)
  2. unknown number of DSD infants that will be referred within a year to the Department of Growth and Reproduction; estimation: 15 DSD infants.
  3. 400 parents of healthy infants (200 fathers and 200 mothers) - unknown number of parents of DSD patients
Criteria

Inclusion Criteria:

  • Singleton pregnancy
  • Maternal and paternal Caucasian origin
  • Maternal pre-pregnancy BMI between 18 and 35 kg/m2
  • No serious maternal illness, including no pre-existing maternal diabetes nor thyroid gland diseases
  • Term pregnancy (week 37+0 to 41+7)
  • No gestational diabetes
  • No fetal malformations or chromosomal disorders
  • Birth weight of child between 3rd and 97th percentile

Only healthy infants born at term will be included in the study which all prospective participants will be informed of.

Exclusion Criteria:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02784184


Locations
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Denmark
Department of Growth and Reproduction, Rigshospitalet
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
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Study Chair: Anders Juul, Prof. Rigshospitalet, Denmark
Principal Investigator: Alexander S Busch, MD Rigshospitalet, Denmark
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Responsible Party: Anders Juul, Anders Juul, MD, PhD, DmSc, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT02784184    
Other Study ID Numbers: RH-H-15014876
RH-2015-210-04146 ( Other Identifier: Danish Data Protection Agency )
First Posted: May 27, 2016    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Anders Juul, Rigshospitalet, Denmark:
Hypothalamic-pituitary-gonadal axis
Additional relevant MeSH terms:
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Disorders of Sex Development
Urogenital Abnormalities
Congenital Abnormalities
Gonadal Disorders
Endocrine System Diseases