Sebum Measurement in Newborn to Detect Hyperexposure to Androgens

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.

Study Overview

• Status: Recruiting
• Conditions: Polycystic Ovary Syndrome
• Intervention / Treatment: Diagnostic test: Sebum test

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

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Roy Homburg; Phone Number: 07484608134; Email: royhomburg@gmail.com
• Study Contact Backup: Name: claudia Rapperport; Phone Number: 02085105555; Email: claudia.r@doctors.org.uk

Study Locations

• United Kingdom
  • London, United Kingdom, E9 6SR
    • Recruiting
    • Homerton Fertility Centre
    • Contact: Claudia Rapperport; Phone Number: 02085105211; Email: claudia.r@doctors.org.uk
    • Contact: Roy Homburg, FROG; Phone Number: 02085105211; Email: royhomburg@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 minutes to 1 day (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Study group; Maternal PCOS	Diagnostic test: Sebum test; Measuring sebum in newborn; Other Names: Sebum measurements
ACTIVE_COMPARATOR: Comaprator; Non-PCOS pregnant women	Diagnostic test: Sebum test; Measuring sebum in newborn; Other Names: Sebum measurements

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	30 seconds

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maternal testosterone levels	The correlation between the maternal blood levels of androgens during pregnancy and the quantity of sebum produced by the newborn?	1 minute
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?	15 minute

Collaborators and Investigators

• Sponsor: Homerton University Hospital NHS Foundation Trust
• Investigators: Study Director: Roy Homburg, Homerton University Hospital NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 8, 2019
• Primary Completion (ANTICIPATED): December 31, 2022
• Study Completion (ANTICIPATED): December 31, 2022

Study Registration Dates

• First Submitted: August 20, 2019
• First Submitted That Met QC Criteria: August 20, 2019
• First Posted (ACTUAL): August 22, 2019

Study Record Updates

• Last Update Posted (ACTUAL): June 21, 2022
• Last Update Submitted That Met QC Criteria: June 17, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Endocrine System Diseases; Ovarian Cysts; Cysts; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Polycystic Ovary Syndrome
• Other Study ID Numbers: 120853

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: May share after publication.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No