Study About Lymphocytes Change During Menstrual Cycle in Women of Child-bearing Age

March 6, 2017 updated by: Shihua Bao, Shanghai First Maternity and Infant Hospital

The investigators are going to select the normal child-bearing period women as the study subjects and draw their peripheral blood to observe and analyze the change of quantity and percentage of lymphocyte subsets along with the change of menstrual cycle.

Recording their BMI\menstrual history\and childbearing history, the investigators would select 300 healthy women in 6 different age groups which are aged 20-24, aged 25-29, aged 30-34, aged35-39, aged 40-44 and aged 45-49, then draw 1-2 ml blood form their peripheral vein (adding EDTA for anti-coagulation). The investigators are going to perform routine examination on the blood samples and detect T\B\NK lymphocyte through flow cytometry (FCM), thus calculating the absolute number of every species of lymphocyte. The investigators make assessment for the cellular immune function of the women during child-bearing period via comparing distinction in percentage and absolute number of every lymphocyte subset among reproductive-age women in different ages.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China, 200051
        • Recruiting
        • Shanghai first Maternity and Infant health hospital, Tong Ji University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 49 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

healthy women of child-bearing age

Description

Inclusion Criteria:

  • Women aged 20-49;
  • Having a regular menstrual cycle of which the menstrual period is between day 3-7, and the period between day 25-35;
  • Excluding internal and surgical disease (after having variety of physical examination such as electrocardiogram/hepatic and renal function/blood routine and urine routine).

Exclusion Criteria:

  • Having experienced severe allergies, trauma history and/or operation history within 3 months;
  • With a history of mental illness and/or family history of mental illness;
  • Limb disabled;
  • Taking medicine within one month;
  • Suffering major events or having mood swings.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
observational group
Observational Study about Lymphocytes Change during Menstrual Cycle in Women of Child-bearing Age

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
the percentage of lymphocyte subsets
Time Frame: through study completion, an average of 1 year
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai First Maternity and Infant Hospital

Investigators

  • Study Chair: Tao Duan, Shanghai First Maternity and Infant Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2016

Primary Completion (Actual)

March 1, 2017

Study Completion (Anticipated)

December 10, 2017

Study Registration Dates

First Submitted

October 26, 2016

First Submitted That Met QC Criteria

October 31, 2016

First Posted (Estimate)

November 1, 2016

Study Record Updates

Last Update Posted (Actual)

March 8, 2017

Last Update Submitted That Met QC Criteria

March 6, 2017

Last Verified

November 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • ShanghaiFMIH-RI

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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