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

Homerton University Hospital NHS Foundation Trust

Status: Completed

Conditions: Polycystic Ovary Syndrome

Treatments: Other: Sebutape

Study type: Interventional

Funder types: Other

Identifiers

NCT02654548

FE1302

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

PCOS women and babies

Experimental group

Description:

Sebum output using Sebutape on post-partum PCOS women and new born babies.

Treatment:

Other: Sebutape

Non-PCOS women and babies

Active Comparator group

Description:

Sebum output using Sebutape on post-partum non-PCOS women and new born babies.

Treatment:

Other: Sebutape