Sebum Excretion in Neonates of Women With Polycystic Ovary Syndrome (PCOS)

Sebum Excretion in Neonates of Women With Polycystic Ovary Syndrome (PCOS): Does Increased Skin Greasiness in the First Week of Life Predict Subsequent Development of the Syndrome? A Cohort Study

To investigate whether women with polycystic ovary syndrome who are post-partum excrete higher levels of sebum in comparison to healthy controls due to high levels of androgens.

Study Overview

• Status: Completed
• Conditions: Polycystic Ovary Syndrome
• Intervention / Treatment: Other: Sebutape

Detailed Description

First degree relatives of women with PCOS have a 3-4 fold increased prevalence of the syndrome compared with the general population, suggesting an inherited genetic predisposition. Many investigations into possible candidate genes for PCOS susceptibility have hypothesised the incomplete penetrance of a dominant gene, although no consensus has been achieved as to any exact genetic polymorphisms which may be culpable.

Primate studies have offered credence to the theory that genomic imprinting is influenced by environmental hyperandrogenism and the hypothesis of intra-uterine exposure to excess androgens as a cause of PCOS is gaining momentum (Abbott et al, 2010). At birth, both mother and neonate are influenced by an identical hormone profile, and it is therefore expected that sebum excretion rates (a correlate of androgen excess) will be higher in those neonates born to mothers with PCOS when compared to those without. This would account for the observed familial transition of PCOS (Legro et al, 1998; Vink et al, 2006), and support the hypothesis that in-utero hyperandrogenism primes differentiating tissues for later expression of the PCOS phenotype in adolescence.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, E9 6SR
    • Homerton Fertility Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Women (with and without a diagnosis of polycystic ovarian syndrome) aged 18-40 with an uncomplicated singleton pregnancy, who deliver a female baby at term (37 weeks gestation or longer). Women in the PCOS cohort will be defined by all the ESHRE/ASRM Rotterdam criteria. Women in the control group, non-PCOS who deliver a female baby will be age matched to the PCOS group. Conception method (natural/assisted) and maternal parity does not affect inclusion but will be documented for subsequent analysis.

Exclusion Criteria:

• baby boys

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PCOS women and babies; Sebum output using Sebutape on post-partum PCOS women and new born babies.	Other: Sebutape; Women who consent to the study will have a sebutape attached to their and their babies foreheads to measure the levels of androgens.
Active Comparator: Non-PCOS women and babies; Sebum output using Sebutape on post-partum non-PCOS women and new born babies.	Other: Sebutape; Women who consent to the study will have a sebutape attached to their and their babies foreheads to measure the levels of androgens.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Sebum output using Sebutape	18 months

Collaborators and Investigators

• Sponsor: Homerton University Hospital NHS Foundation Trust
• Investigators: Principal Investigator: Roy Homburg, FROG, Professor

Publications and helpful links

General Publications

• Homburg R, Gudi A, Shah A, M Layton A. A novel method to demonstrate that pregnant women with polycystic ovary syndrome hyper-expose their fetus to androgens as a possible stepping stone for the developmental theory of PCOS. A pilot study. Reprod Biol Endocrinol. 2017 Aug 8;15(1):61. doi: 10.1186/s12958-017-0282-1.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2013
• Primary Completion (Actual): February 1, 2016
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: January 11, 2016
• First Submitted That Met QC Criteria: January 12, 2016
• First Posted (Estimate): January 13, 2016

Study Record Updates

• Last Update Posted (Actual): August 22, 2019
• Last Update Submitted That Met QC Criteria: August 20, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Endocrine System Diseases; Disease; Ovarian Cysts; Cysts; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Polycystic Ovary Syndrome; Syndrome
• Other Study ID Numbers: FE1302

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No