Assesment of Salivary Alpha-amylase Levels Before and After Ovulation

Assesment of Salivary Alpha-amylase Levels Before and After Ovulation: A Randomized Controlled Trial

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 Overview

• Status: Unknown
• Conditions: Salivary Amylase
• Intervention / Treatment: Other: Salivary alpha-Amylases

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 Type: Observational
• Enrollment (Actual): 100

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Pcos women will included the study population. Because ovulation don't happen.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
study group; Reproductive age women with polycystic ovary syndrome and irregular menses (Salivary Alpha-amylase Levels of 3rd and 24th day of menstrual cyclus)	Other: Salivary alpha-Amylases; Investigators will collect Salivary alpha-Amylases before and after ovulation
control group; Reproductive age women with regular menses (Salivary Alpha-amylase level of 3rd and 24th day of menstrual cyclus)	Other: Salivary alpha-Amylases; Investigators will collect Salivary alpha-Amylases before and after ovulation

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
• Investigators: Principal Investigator: Mustafa Öztürk, M.D, Etimesgut Military Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Anticipated): February 1, 2016
• Study Completion (Anticipated): March 1, 2016

Study Registration Dates

• First Submitted: January 11, 2016
• First Submitted That Met QC Criteria: January 22, 2016
• First Posted (Estimate): January 27, 2016

Study Record Updates

• Last Update Posted (Estimate): January 27, 2016
• Last Update Submitted That Met QC Criteria: January 22, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: ovulation; Salivary Alpha-amylase
• Other Study ID Numbers: Gulhane School of Medicine

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO