Effect of Pregnancy on Androgenic Steroids in Different Genetic Panels

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of Pregnancy on Androgenic Steroids in Different Genetic Panels

Conditions
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Sex Steroids

Intervention / Treatment
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* Biological: Urine sample collection
* Biological: Saliva collection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Urine sample collection|A urine sample will be collected in each of the 3 trimesters of pregnancy, and also at 6 weeks post partum.|
|Biological: Saliva collection|A saliva sample will be collected at one time point during the study - likely at the initial baseline visit.|

What is the study measuring?
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Primary Outcome Measures

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