Sex Steroids
Conditions
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.
Interventions
BIOLOGICALUrine sample collection
A urine sample will be collected in each of the 3 trimesters of pregnancy, and also at 6 weeks post partum.
BIOLOGICALSaliva collection
A saliva sample will be collected at one time point during the study - likely at the initial baseline visit.
Sponsors
Unity Health Toronto
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Outcome results
None listed