Assesment of Salivary Alpha-amylase Levels Before and After Ovulation

• Conditions: Salivary Amylase
• Interventions: Other: Salivary alpha-Amylases

• Registration Number: NCT02664480
• Lead Sponsor: Saglik Bilimleri Universitesi Gulhane Tip Fakultesi

Brief Summary

Investigators aimed to investigate whether there is an association between ovulation and salivatory alpha amylase (sAA) activity in menstrual cycles during a month period in a group of reproductive women.

Detailed Description

Saliva is a readily available specimen, which can be collected by noninvasive procedures and contains many hormones, drugs and antibodies of interest in screening and diagnosis. With a salivary specimen, one can collect multiple specimens at the optimum times for diagnostic information. Saliva can be collected in remote sites by unskilled personnel and, is stable at ambient temperatures for several weeks. Because of diurnal and monthly variations, several steroid hormones need multiple samples collected early in the morning or late at night or at the same time every day for a month to give meaningful results. Such collections are often very expensive, inconvenient or impossible to do with blood.

Investigators aimed to investigate whether there is an association between ovulation and salivatory alpha amylase (sAA) activity in menstrual cycles during a month period in a group of reproductive women.

Study Timeline

• Status Verified: 2016-01
• Study Start: 2016-01
• Study First Submitted: 2016-01-11
• Study First Submitted QC: 2016-01-22
• Last Update Submitted: 2016-01-22
• Study First Posted: 2016-01-27
• Last Update Posted: 2016-01-27
• Primary Completion: 2016-02
• Study Completion: 2016-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

• Clinical diagnosis of PCOS (study group)
• Reproductive age regular menses women

Exclusion Criteria

• pregnancy,
• breastfeeding,
• known liver disease,
• alcohol abuse,
• diabetes mellitus,
• smoking
• treatment with oral glucocorticoids
• treatment with hormonal contraceptives.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
control group	Salivary alpha-Amylases	Reproductive age women with regular menses (Salivary Alpha-amylase level of 3rd and 24th day of menstrual cyclus)
study group	Salivary alpha-Amylases	Reproductive age women with polycystic ovary syndrome and irregular menses (Salivary Alpha-amylase Levels of 3rd and 24th day of menstrual cyclus)

Primary Outcome Measures

Name	Time	Method
Changes of Salivary Alpha-amylase activity	3rd and 24th day of menstrual cyclus	Saliva samples will be taken 2 times during the menstrual cyclus (3th day and 24th day).