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Clinical Trials/NCT02951832
NCT02951832
Unknown
Not Applicable

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

Shanghai First Maternity and Infant Hospital1 site in 1 country200 target enrollmentOctober 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Lymphocyte Subsets in Women of Child-bearing Age
Sponsor
Shanghai First Maternity and Infant Hospital
Enrollment
200
Locations
1
Primary Endpoint
the percentage of lymphocyte subsets
Last Updated
9 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
October 2016
End Date
December 10, 2017
Last Updated
9 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Shihua Bao

Principal Investigator

Shanghai First Maternity and Infant Hospital

Eligibility Criteria

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.

Outcomes

Primary Outcomes

the percentage of lymphocyte subsets

Time Frame: through study completion, an average of 1 year

Study Sites (1)

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