Sebum Measurement in Newborn to Detect Hyperexposure to Androgens

• Sponsor: Homerton University Hospital NHS Foundation Trust (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04065100
• Collaborator: (none)
• Enrollment: 200
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 41.8
• Patients Per Site Per Month: 4.8

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Polycystic Ovary Syndrome	Diagnostic Test: Sebum test	N/A

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 Design

• Study Type: Interventional
• Anticipated 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.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: Jul 8, 2019
• Anticipated Primary Completion Date: Dec 31, 2022
• Anticipated Study Completion Date: Dec 31, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Sebum secretion [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 [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 [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?

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Minutes to 1 Day
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Homerton Fertility Centre	London		United Kingdom	E9 6SR

Sponsors and Collaborators

• Homerton University Hospital NHS Foundation Trust

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Homerton University Hospital NHS Foundation Trust
• ClinicalTrials.gov Identifier: NCT04065100
• Other Study ID Numbers: 120853
• First Posted: Aug 22, 2019
• Last Update Posted: Jun 21, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Polycystic Ovary Syndrome

Study Results

No Results Posted as of Jun 21, 2022