Sebum Measurement in Newborn to Detect Hyperexposure to Androgens

NCT04065100 | Unknown

• 1 other identifier: 120853
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Polycystic Ovary Syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Maternal testosterone levels

  1 minute

• Ano-genital distance and finger length in the newborn

  15 minute

Study Arms (2)

Study group

EXPERIMENTAL

Maternal PCOS

Diagnostic Test: Sebum test

Comaprator

ACTIVE COMPARATOR

Non-PCOS pregnant women

Diagnostic Test: Sebum test

Interventions

Sebum test DIAGNOSTIC_TEST

Measuring sebum in newborn

Also known as: Sebum measurements

Comaprator; Study group

Eligibility Criteria

• Age: 30 Minutes - 1 Day
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Patients who decline consent

Sponsors & Collaborators

• Homerton University Hospital NHS Foundation Trust: lead

Study Sites (1)

Homerton Fertility Centre

London, E9 6SR, United Kingdom

RECRUITING

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Study Officials

• Roy Homburg

  Homerton University Hospital NHS Foundation Trust

  STUDY DIRECTOR

Central Study Contacts

Roy Homburg

CONTACT

07484608134; royhomburg@gmail.com

claudia Rapperport

CONTACT

02085105555; claudia.r@doctors.org.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 20, 2019
• First Posted: August 22, 2019
• Study Start: July 8, 2019
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: June 21, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)