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Sebum Measurement in Newborn to Detect Hyperexposure to Androgens

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ClinicalTrials.gov Identifier: NCT04065100
Recruitment Status : Recruiting
First Posted : August 22, 2019
Last Update Posted : August 28, 2019
Sponsor:
Information provided by (Responsible Party):
Homerton University Hospital NHS Foundation Trust

Brief Summary:
The source of PCOS is unknown. Our hypothesis is that over exposure to testosterone of the foetus in utero alters the expression of genes thought to be involved in the cause of PCOS.

Condition or disease Intervention/treatment Phase
Polycystic Ovary Syndrome Diagnostic Test: Sebum test Not Applicable

Detailed Description:

Polycystic ovary syndrome (PCOS) affecting 10-15% of the female population causes excess hair, acne, irregular/absent ovulation, infertility and is associated with hypertension, diabetes, heart attacks and stroke in later life.

The economic care-related burden of the syndrome is estimated at $4.36 billion/year in the USA. The root cause is unknown and although mostly familial, the offending genes are unknown. We believe that excess testosterone, to which the foetus is exposed during its life in the womb, causes development of PCOS in adult life. If a mother with PCOS exposes her foetus to high testosterone levels compared to one with no PCOS, this would be the first step in proving the developmental hypothesis for PCOS, opening the door to methods to prevent the appearance of the distressing symptoms of PCOS in adult life.

With no access to the foetal environment, we have used the surrogate measure of sebum on the skin of the newborn, 99% influenced by testosterone. Our pilot study (Homburg et al, 2017) used absorbent paper to measure sebum excretion in PCOS and controls within 24 hours and 1-24 weeks after birth in mother and baby. Higher sebum production in female babies of PCOS mothers strongly supported our hypothesis.

The present proposal utilizes a 30-second, non-invasive, quantitative measurement of sebum (Sebumeter®) in the newborn from PCOS mothers and controls, within 24 hours of birth. We will correlate results with other features in both female and male newborn that may suggest hyper-exposure to testosterone and with maternal testosterone levels in the blood. If confirming the findings of our pilot study in line with the developmental theory of PCOS, this could be used within 24 hours of birth to predict development of PCOS in adult life, induce measures to prevent the symptoms of PCOS and reduce the enormous health burden on patients and economies

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: pregnant women with and without PCOS will be recruited in mid pregnancy. the newborn will be examined for sebum production and the two groups compared with each other and with and maternal testosterone levels.
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Sebum Measurement in Newborn to Detect Hyperexposure to Androgens
Actual Study Start Date : July 8, 2019
Estimated Primary Completion Date : July 1, 2021
Estimated Study Completion Date : July 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Study group
Maternal PCOS
Diagnostic Test: Sebum test
Measuring sebum in newborn
Other Name: Sebum measurements

Active Comparator: Comaprator
Non-PCOS pregnant women
Diagnostic Test: Sebum test
Measuring sebum in newborn
Other Name: Sebum measurements




Primary Outcome Measures :
  1. Sebum secretion [ Time Frame: 30 seconds ]
    Do term babies of mothers with PCOS have significantly increased sebum output in the neonatal period compared with those from mothers without PCOS


Secondary Outcome Measures :
  1. Maternal testosterone levels [ Time Frame: 1 minute ]
    The correlation between the maternal blood levels of androgens during pregnancy and the quantity of sebum produced by the newborn?

  2. Ano-genital distance and finger length in the newborn [ Time Frame: 15 minute ]
    Correlation of the level of sebum production in the neonate with other measures (ano-genital distance, finger lengths) of androgen exposure of the foetus during pregnancy?



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Ages Eligible for Study:   up to 1 Day   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Women (with and without a diagnosis of polycystic ovarian syndrome) aged 18-40 with an uncomplicated singleton pregnancy, who deliver a baby at term (37 weeks gestation or longer). Women in the PCOS cohort will be defined by the ESHRE/ASRM Rotterdam criteria. Women with no signs of PCOS who deliver a term baby will serve as the control group.

Exclusion Criteria:

Patients who decline consent


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): NCT04065100


Contacts
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Contact: Roy Homburg 07484608134 royhomburg@gmail.com
Contact: claudia Rapperport 02085105555 claudia.r@doctors.org.uk

Locations
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United Kingdom
Homerton Fertility Centre Recruiting
London, United Kingdom, E9 6SR
Contact: Claudia Rapperport    02085105211    claudia.r@doctors.org.uk   
Contact: Roy Homburg, FROG    02085105211    royhomburg@gmail.com   
Sponsors and Collaborators
Homerton University Hospital NHS Foundation Trust
Investigators
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Study Director: Roy Homburg Homerton University Hospital NHS Foundation Trust
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Responsible Party: Homerton University Hospital NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT04065100    
Other Study ID Numbers: 120853
First Posted: August 22, 2019    Key Record Dates
Last Update Posted: August 28, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: May share after publication.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Polycystic Ovary Syndrome
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases