Sebum Measurement in Newborn to Detect Hyperexposure to Androgens
Primary Purpose
Polycystic Ovary Syndrome
Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Sebum test
Sponsored by
About this trial
This is an interventional diagnostic trial for Polycystic Ovary Syndrome
Eligibility 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
Sites / Locations
- Homerton Fertility CentreRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Study group
Comaprator
Arm Description
Maternal PCOS
Non-PCOS pregnant women
Outcomes
Primary Outcome Measures
Sebum secretion
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
Maternal testosterone levels
The correlation between the maternal blood levels of androgens during pregnancy and the quantity of sebum produced by the newborn?
Ano-genital distance and finger length in the newborn
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?
Full Information
NCT ID
NCT04065100
First Posted
August 20, 2019
Last Updated
June 17, 2022
Sponsor
Homerton University Hospital NHS Foundation Trust
1. Study Identification
Unique Protocol Identification Number
NCT04065100
Brief Title
Sebum Measurement in Newborn to Detect Hyperexposure to Androgens
Official Title
Sebum Measurement in Newborn to Detect Hyperexposure to Androgens
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 8, 2019 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Homerton University Hospital NHS Foundation Trust
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Non-Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Study group
Arm Type
Experimental
Arm Description
Maternal PCOS
Arm Title
Comaprator
Arm Type
Active Comparator
Arm Description
Non-PCOS pregnant women
Intervention Type
Diagnostic Test
Intervention Name(s)
Sebum test
Other Intervention Name(s)
Sebum measurements
Intervention Description
Measuring sebum in newborn
Primary Outcome Measure Information:
Title
Sebum secretion
Description
Do term babies of mothers with PCOS have significantly increased sebum output in the neonatal period compared with those from mothers without PCOS
Time Frame
30 seconds
Secondary Outcome Measure Information:
Title
Maternal testosterone levels
Description
The correlation between the maternal blood levels of androgens during pregnancy and the quantity of sebum produced by the newborn?
Time Frame
1 minute
Title
Ano-genital distance and finger length in the newborn
Description
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?
Time Frame
15 minute
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Minutes
Maximum Age & Unit of Time
1 Day
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Roy Homburg
Phone
07484608134
Email
royhomburg@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
claudia Rapperport
Phone
02085105555
Email
claudia.r@doctors.org.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roy Homburg
Organizational Affiliation
Homerton University Hospital NHS Foundation Trust
Official's Role
Study Director
Facility Information:
Facility Name
Homerton Fertility Centre
City
London
ZIP/Postal Code
E9 6SR
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claudia Rapperport
Phone
02085105211
Email
claudia.r@doctors.org.uk
First Name & Middle Initial & Last Name & Degree
Roy Homburg, FROG
Phone
02085105211
Email
royhomburg@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
May share after publication.
Learn more about this trial
Sebum Measurement in Newborn to Detect Hyperexposure to Androgens
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