Lymphocyte Subsets in Women of Child-bearing AgeNCT02951832
Study About Lymphocytes Change During Menstrual Cycle in Women of Child-bearing Age
An observational study of Lymphocyte Subsets in Women of Child-bearing Age, run by Shanghai First Maternity and Infant Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Lymphocyte Subsets in Women of Child-bearing Age
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Oct 2016to 10 Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: healthy women of child-bearing age
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Yan Yan contact
China1 site, 1 recruiting
- Recruiting
Shanghai first Maternity and Infant health hospital, Tong Ji University
Shanghai, 200051
Shihua Bao, PhD, 86-21-20261430 ext. 2012, baoshihua@tongji.edu.cn
Yan Yan, Master, 86-21-20261430 ext. 2012, shtjyanyan@163.com
About this study
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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| observational group | Observational Study about Lymphocytes Change during Menstrual Cycle in Women of Child-bearing Age |
What is being measured
The primary outcome is the main question the study is designed to answer.
the percentage of lymphocyte subsets
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2016 (estimated)
- Study startOct 2016
- Primary completion1 Mar 2017
- Study completion10 Dec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphocyte Subsets in Women of Child-bearing AgeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai First Maternity and Infant Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shihua Bao, Shanghai First Maternity and Infant Hospital
- Investigators
- Tao Duan, Study chair, Shanghai First Maternity and Infant Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02951832
- Sponsor's protocol ID
- ShanghaiFMIH-RI
- Status last verified
- Nov 2016
- First submitted
- 26 Oct 2016
- Last updated
- 8 Mar 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study About Lymphocytes Change During Menstrual Cycle in Women of Child-bearing Age
- ClinicalTrials.gov ID
- NCT02951832
- Acronym / sponsor ID
- ShanghaiFMIH-RI
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Shanghai First Maternity and Infant HospitalUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- 1 Mar 2017 (actual)
- Study completion
- 10 Dec 2017 (estimated)
- First posted
- 1 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| observational group | – | –Observational Study about Lymphocytes Change during Menstrual Cycle in Women of Child-bearing Age |
Who may qualify
- Ages
- 20 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- healthy women of child-bearing age
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
the percentage of lymphocyte subsets
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2017.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yan Yan contact
Tao Duan study chair
Shanghai First Maternity and Infant Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lymphocyte Subsets in Women of Child-bearing Age, run by Shanghai First Maternity and Infant Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yan Yan (86-18964213238), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the percentage of lymphocyte subsets (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2017.