Sebum Excretion in Neonates of Women With Polycystic Ovary Syndrome (PCOS)
Primary Purpose
Polycystic Ovary Syndrome
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Sebutape
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 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
Sites / Locations
- Homerton Fertility Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
PCOS women and babies
Non-PCOS women and babies
Arm Description
Sebum output using Sebutape on post-partum PCOS women and new born babies.
Sebum output using Sebutape on post-partum non-PCOS women and new born babies.
Outcomes
Primary Outcome Measures
Sebum output using Sebutape
Secondary Outcome Measures
Full Information
NCT ID
NCT02654548
First Posted
January 11, 2016
Last Updated
August 20, 2019
Sponsor
Homerton University Hospital NHS Foundation Trust
1. Study Identification
Unique Protocol Identification Number
NCT02654548
Brief Title
Sebum Excretion in Neonates of Women With Polycystic Ovary Syndrome (PCOS)
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
June 2013 (Actual)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
March 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Homerton University Hospital NHS Foundation Trust
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
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
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PCOS women and babies
Arm Type
Experimental
Arm Description
Sebum output using Sebutape on post-partum PCOS women and new born babies.
Arm Title
Non-PCOS women and babies
Arm Type
Active Comparator
Arm Description
Sebum output using Sebutape on post-partum non-PCOS women and new born babies.
Intervention Type
Other
Intervention Name(s)
Sebutape
Intervention Description
Women who consent to the study will have a sebutape attached to their and their babies foreheads to measure the levels of androgens.
Primary Outcome Measure Information:
Title
Sebum output using Sebutape
Time Frame
18 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roy Homburg, FROG
Organizational Affiliation
Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Homerton Fertility Centre
City
London
ZIP/Postal Code
E9 6SR
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
28789693
Citation
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.
Results Reference
derived
Learn more about this trial
Sebum Excretion in Neonates of Women With Polycystic Ovary Syndrome (PCOS)
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