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Genitalia and Androgen in New Born Girls (VOGE)

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ClinicalTrials.gov Identifier: NCT02826278
Recruitment Status : Unknown
Verified July 2016 by Hospices Civils de Lyon.
Recruitment status was:  Recruiting
First Posted : July 7, 2016
Last Update Posted : July 7, 2016
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Brief Summary:

Normal values for female external genitalia size at birth, particularly clitoris and blood level of androgens are not well known. This study's aim is to collect normal values in 180 newborn girls of 24 to 41 weeks of pregnancy, and to build genitalia growth charts according to gestational age and birth weight.

The investigators will measure clitoris, genito-anal ratio using a small plastic caliper, at birth, and their evolution until Day 3 of life (if the child is still at the hospital).

The investigators also want to establish normal values of blood testosterone, 17-hydroxyprogesterone, delta4-androstenedione, 21-deoxycortisol, 11-deoxycortisol, deoxycorticosterone, corticosterone, dehydroepiandrostenedione, and dihydrotestosterone), using samples taken for systematic post natal screening of diseases (only in new born of 35 or more weeks of birth).

This is an observational prospective study.


Condition or disease Intervention/treatment
Newborn Genitalia Other: External genitalia measurements in female newborns

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Study Type : Observational
Estimated Enrollment : 180 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study Protocol: Reference Values for External Genitalia and Androgen Blood Level in New Born Girls
Study Start Date : October 2014
Estimated Primary Completion Date : August 2016
Estimated Study Completion Date : August 2016

Group/Cohort Intervention/treatment
Healthy female newborns
Healthy female newborns 24 to 41 weeks of pregnancy without sexual development disturbances
Other: External genitalia measurements in female newborns



Primary Outcome Measures :
  1. length of the clitoris [ Time Frame: Day 1 ]
    The measurement is performed on the supine child, with flexed hips and knees retained by the nurse or the nursery nurse. The clitoris will be delimited using cavernosa palpation. The clitoris length will be measured from maxima lablias'root to the top of clitoris, excluding cutaneous cover. Measurements are performed using an-8 cm plastic caliper.

  2. length of the clitoris [ Time Frame: Day 3 ]
    The measurement is performed on the supine child, with flexed hips and knees retained by the nurse or the nursery nurse. The clitoris will be delimited using cavernosa palpation. The clitoris length will be measured from maxima lablias'root to the top of clitoris, excluding cutaneous cover. Measurements are performed using an-8 cm plastic caliper


Secondary Outcome Measures :
  1. clitoris width [ Time Frame: Day 1 ]
    The clitoris will be measured at its base, using an-8 cm plastic caliper.

  2. clitoris width [ Time Frame: Day 3 ]
    Measurement will be done if newborns stay at the hospital

  3. anogenital ratio [ Time Frame: Day 1 ]
    The ano-genital ratio is the ratio between 1) the distance from anus center to the base of clitoris and 2) the distance from anus center and the posterior commissure of the vulva frenulum.

  4. anogenital ratio [ Time Frame: Day 3 ]
    Measurement will be done if newborns stay at the hospital

  5. Blood level of testosterone [ Time Frame: Day 3 ]
    This dosage will be performed using a 1.5 ml blood sample taken for screening purpose (for routine systematic post natal screening) only in newborn over 35 WA

  6. Blood level of 17-hydroxyprogesterone [ Time Frame: Day 3 ]
    This dosage will be performed using a 1.5 ml blood sample taken for screening purpose (for routine systematic post natal screening) only in newborn over 35 WA

  7. Blood level of delta4-androstenedione [ Time Frame: Day 3 ]
    This dosage will be performed using a 1.5 ml blood sample taken for screening purpose (for routine systematic post natal screening) only in newborn over 35 WA

  8. Blood level of 21-deoxycortisol [ Time Frame: Day 3 ]
    This dosage will be performed using a 1.5 ml blood sample taken for screening purpose (for routine systematic post natal screening) only in newborn over 35 WA

  9. Blood level of corticosterone [ Time Frame: Day 3 ]
    This dosage will be performed using a 1.5 ml blood sample taken for screening purpose (for routine systematic post natal screening) only in newborn over 35 WA

  10. Blood level of dihydrotestosterone [ Time Frame: Day 3 ]
    This dosage will be performed using a 1.5 ml blood sample taken for screening purpose (for routine systematic post natal screening) only in newborn over 35 WA



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Ages Eligible for Study:   up to 3 Days   (Child)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Female newborns, with gestational ages of 24 to 41 weeks of pregnancy.
Criteria

Inclusion Criteria:

  • Healthy female newborns 24 to 41 weeks of pregnancy without sexual development disturbances. Dysmature children - i.e. those with a - 2DS birth weight or height at are not excluded.

Exclusion Criteria:

  • Sexual development abnormality, diagnosed pre- or post- birth, endocrine disorder, obstetric trauma affecting genitalia, malformation syndrome, midline abnormalities, congenital cancer, maternal ovary or adrenal tumor diagnosed during pregnancy, mother or father's treatment during pregnancy likely to virilize the fetus, family history of congenital adrenal hyperplasia or neurofibromatosis

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): NCT02826278


Contacts
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Contact: Claire-Lise GAY, MD 472 129 531 ext +33 claire-lise.gay@chu-lyon.fr
Contact: Cornu Catherine, MD 472 357 231 ext +33 catherine.cornu@chu-lyon.fr

Locations
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France
Hopital Femme Mere Enfant Recruiting
Bron, France
Contact: Claire-Lise Gay, MD         
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Principal Investigator: Claire-Lise GAY, MD Hospices Civils de Lyon

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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT02826278     History of Changes
Other Study ID Numbers: 69HCL14_0451
First Posted: July 7, 2016    Key Record Dates
Last Update Posted: July 7, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Hospices Civils de Lyon:
Newborn genitalia
reference charts

Additional relevant MeSH terms:
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Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs