Effect of Pregnancy on Androgenic Steroids in Different Genetic Panels

Not Applicable

Completed

• Conditions: Sex Steroids

• Registration Number: NCT03064412
• Lead Sponsor: Unity Health Toronto

Brief Summary

Androgens are important sex steroids in women. Androgens influence protein synthesis and muscle growth, are involved in maturation of the reproductive organs, have a fat reducing effect , have a negative effect on the serum lipid profile, and may also increase insulin resistance and coagulation activity. The role of androgens in women is not clear. This study is aimed at learning about the amount of androgen and its actions in pregnant women. This study is also looking to see if there are specific patient factors (such as genetics) that change the amount of androgen and its activity.

Detailed Description

There is a lot of information about the main female sex hormones such as estrogens and progesterones (the main female sex hormones and the most important in menstrual , reproductive cycles and pregnancy) . However there is little information about androgens in pregnant women. It is known that certain illnesses, chemicals and dietary products might change the amount of androgen and its actions, which could affect the mother and her baby. It is also known that there are differences between the androgen levels in different people, and in different ethnic groups. These differences are mostly due to genetic factors. The goal of this study is to learn about the androgen levels in healthy pregnant women and if genetic or clinical factors (for example age, trimester of pregnancy, parity, ethnicity, etc.) play a role in changing the androgen amount and action, throughout pregnancy and after delivery.

Study Timeline

• Study Start: 2014-09
• Primary Completion: 2017-01
• Study Completion: 2017-01
• Study First Submitted: 2017-02-22
• Study First Submitted QC: 2017-02-22
• Study First Posted: 2017-02-27
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-20
• Last Update Posted: 2017-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 70

Inclusion Criteria

• healthy women without drug treatment, in the age range of 18-40 years

Exclusion Criteria

• Any chronic disease such as Hypertension or Diabetes Mellitus
• Positive for HIV, hepatitis, Syphilis
• Abnormal laboratory test results (e.g. abnormal TSH, glucose, creatinine, HIV, HBV, VDRL)
• PCOS
• Ongoing hormonal treatment-e.g. progesterone, estrogen or other
• Smoking cigarettes, alcohol, regular substance use
• Confirmed or suspected abuse of drugs
• Chronic prescription drugs
• Pre-existing diabetes or GDM in last pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Changes in sex steroids	1st trimester (1-12 weeks gestation), 2nd trimester (13-28 weeks gestation), 3rd trimester (28-40 weeks gestation), 6 weeks post-partum	Changes to levels of sex steroids throughout pregnancy and after delivery