Endometrium; SenilityNCT04860310
Panoramic Presentation and Tolerance Mechanism of Human Endometrium Based on Tiangui Theory
An observational study of Endometrium; Senility, run by Heilongjiang University of Chinese Medicine at 1 site in China.
Trial summary
Detailed Description:In the process of women's menstrual cycle, there are different physiology at different time points in a cycle. Change, investigators select women with a menstrual cycle of 28 days and take samples every 3 days. Read more about this study
- Who is it for?
- Ages 21 to 49 years, women only
- Conditions the study is for
- Endometrium; Senility
- What is being tested?
- Endometrial biopsy
- Type of treatment
- Surgery or procedure
- How many people
- 55 participants
- Where
- 1 siteChina
- Study dates
- 8 Jul 2020to 5 Sep 2021
- 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 21 to 49 years
- Women only
- No healthy volunteers
- Adult
Study population: The subject is a healthy woman aged 21/28/35/42/49 years old, BMI=23～25kg/m2, and her menstrual cycle is 28+/-1 day (that is, 2-3 days in advance of each month) , And consistent for the past 6 consecutive months (no more than 1 day before and after, that is, 27-29 days), no IUD was placed in the uterine cavity.
Who may be able to join
- The subject's infertility factors are only male factors and/or fallopian tube factors;
- Age: 21/28/35/42/49 years old (calculated according to the birthday month of the Gregorian calendar, no more than 6 months before and after);
- Body mass index (weight/height square)=23～25kg/m2;
- The menstrual cycle is 28+/-1 days (that is, the menstruation is 2-3 days in advance of each month), and the consistency of the past 6 consecutive months (not more than 1 day before and after, that is, 27-29 days);
- Women with a history of pregnancy are preferred;
- Asexual life during the study period;
- No IUD is placed in the uterine cavity;
- Volunteer to participate in the experiment and sign the informed consent form.
Who cannot join
- Women who have a history of miscarriage;
- Women during pregnancy and breastfeeding;
- Mentally ill;
- Those who have had oral contraceptives or hormonal drugs in the past three months;
- Combined with serious primary diseases such as cardiovascular, cerebrovascular, liver, kidney and hematopoietic system;
- Subjects who have participated in other drug clinical trials within six months;
- Those who have poor compliance and the investigator thinks it is inappropriate to participate in this clinical trial.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Obstetrics and Gynecology,First Affliated Hospital,Heilongjiang University of Chinese Medicine .
Harbin, Heilongjiang, 150040
About this study
Detailed Description:In the process of women's menstrual cycle, there are different physiology at different time points in a cycle.
Change, investigators select women with a menstrual cycle of 28 days and take samples every 3 days.
Read more
Day 4, Day 7, Day 10, Day 13, Day 16, Day 19, Day 22, Day 25, Day 28 days, a total of 10 time points, 20 healthy women were selected, and the transcription, Protein and phosphorylation proteomics, systematically integrated analysis; at the same time, 20 subjects were classified by age group Divide into 4 groups, 21-year-old group, 28-year-old group, 35-year-old group, and 42-year-old group. At the same time, investigators then analyze the differences in the receptivity of the endometrium of different ages.
The experimental design groups are: 21-year-old group, 28-year-old group, 35-year-old group, 42-year-old group, Each group includes D1 group Vs D4 group Vs D7 group Vs D10 group Vs D13 group Vs D16 group Vs D19 group Vs D22 group Vs D25 group Vs D28 group; in phosphorylation modification omics, different time points are compared with each other, Look for transcripts, proteins and phosphorylated proteins that change significantly during the cycle of change. Analyze phosphorylation modification An important role for changing proteins and an important role for cycle changes.
The experiment quantified the proteome and protein acylation modification through TMT (Tandem Mass Tag), and passed GO, KEGG Pathway, Localization, Functional enrichment analysis, Cluster analysis Bioinformatics analysis
- Conditions
- Endometrium; Senility
- Being tested
- Endometrial biopsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endometrial biopsyProcedure or surgery
Subjects need to collect 5ml whole blood (EDTA or heparin anticoagulant) once in the morning on an empty stomach. Endometrial tissue samples were taken during a complete 28-day menstrual cycle, a total of 6 times, and blood was taken to measure the level of gonadal hormones before each sampling.
| Study group | Role | What they receive |
|---|---|---|
| 21 years old group | Not described Receives: Procedure: Endometrial biopsy | |
| 28 years old group | Not described Receives: Procedure: Endometrial biopsy | |
| 35 years old group | Not described Receives: Procedure: Endometrial biopsy | |
| 42 years old group | Not described Receives: Procedure: Endometrial biopsy | |
| 49 years old group | Not described Receives: Procedure: Endometrial biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Panorama of the endometrium
Discovery of inner membrane receptive proteins and pathways
Measured: Menstrual cramps 24 hours, the seventh day of menstruation, LH peak, 72 hours after the peak, the 21st day of menstruation, the 28th day of menstruation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2021
- Study start8 Jul 2020
- Primary completion5 Mar 2021
- Study completion5 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrium; SenilityStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heilongjiang University of Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaoke Wu, Heilongjiang University of Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04860310
- Sponsor's protocol ID
- MOM
- Status last verified
- Sep 2021
- First submitted
- 6 Apr 2021
- Last updated
- 23 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Panoramic Presentation and Tolerance Mechanism of Human Endometrium Based on Tiangui Theory
- ClinicalTrials.gov ID
- NCT04860310
- Acronym / sponsor ID
- MOM
- Conditions
- Endometrium; Senility
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Heilongjiang University of Chinese MedicineUniversity, hospital or other
- Study start
- 8 Jul 2020 (actual)
- Primary completion
- 5 Mar 2021 (actual)
- Study completion
- 5 Sep 2021 (actual)
- First posted
- 26 Apr 2021 (actual)
- 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.
Detailed Description:In the process of women's menstrual cycle, there are different physiology at different time points in a cycle.
Change, investigators select women with a menstrual cycle of 28 days and take samples every 3 days.
Day 4, Day 7, Day 10, Day 13, Day 16, Day 19, Day 22, Day 25, Day 28 days, a total of 10 time points, 20 healthy women were selected, and the transcription, Protein and phosphorylation proteomics, systematically integrated analysis; at the same time, 20 subjects were classified by age group Divide into 4 groups, 21-year-old group, 28-year-old group, 35-year-old group, and 42-year-old group. At the same time, investigators then analyze the differences in the receptivity of the endometrium of different ages.
The experimental design groups are: 21-year-old group, 28-year-old group, 35-year-old group, 42-year-old group, Each group includes D1 group Vs D4 group Vs D7 group Vs D10 group Vs D13 group Vs D16 group Vs D19 group Vs D22 group Vs D25 group Vs D28 group; in phosphorylation modification omics, different time points are compared with each other, Look for transcripts, proteins and phosphorylated proteins that change significantly during the cycle of change. Analyze phosphorylation modification An important role for changing proteins and an important role for cycle changes.
The experiment quantified the proteome and protein acylation modification through TMT (Tandem Mass Tag), and passed GO, KEGG Pathway, Localization, Functional enrichment analysis, Cluster analysis Bioinformatics analysis
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 21 years old group | – | Procedure: Endometrial biopsy |
| 28 years old group | – | Procedure: Endometrial biopsy |
| 35 years old group | – | Procedure: Endometrial biopsy |
| 42 years old group | – | Procedure: Endometrial biopsy |
| 49 years old group | – | Procedure: Endometrial biopsy |
Who may qualify
- Ages
- 21 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The subject is a healthy woman aged 21/28/35/42/49 years old, BMI=23～25kg/m2, and her menstrual cycle is 28+/-1 day (that is, 2-3 days in advance of each month) , And consistent for the past 6 consecutive months (no more than 1 day before and after, that is, 27-29 days), no IUD was placed in the uterine cavity.
Key inclusion criteria (8 listed)
- The subject's infertility factors are only male factors and/or fallopian tube factors;
- Age: 21/28/35/42/49 years old (calculated according to the birthday month of the Gregorian calendar, no more than 6 months before and after);
- Body mass index (weight/height square)=23～25kg/m2;
- The menstrual cycle is 28+/-1 days (that is, the menstruation is 2-3 days in advance of each month), and the consistency of the past 6 consecutive months (not more than 1 day before and after, that is, 27-29 days);
- Women with a history of pregnancy are preferred;
Key exclusion criteria (7 listed)
- Women who have a history of miscarriage;
- Women during pregnancy and breastfeeding;
- Mentally ill;
- Those who have had oral contraceptives or hormonal drugs in the past three months;
- Combined with serious primary diseases such as cardiovascular, cerebrovascular, liver, kidney and hematopoietic system;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endometrial biopsySubjects need to collect 5ml whole blood (EDTA or heparin anticoagulant) once in the morning on an empty stomach. Endometrial tissue samples were taken during a complete 28-day menstrual cycle, a total of 6 times, and blood was taken to measure the level of gonadal hormones before each sampling. | Procedure or surgery | 21 years old group, 28 years old group, 35 years old group, 42 years old group, 49 years old group |
Primary outcome
Panorama of the endometrium
Time frame: Menstrual cramps 24 hours, the seventh day of menstruation, LH peak, 72 hours after the peak, the 21st day of menstruation, the 28th day of menstruation
Discovery of inner membrane receptive proteins and pathways
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2021.
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Endometrium; Senility, run by Heilongjiang University of Chinese Medicine 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 8 inclusion and 7 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: finished, as of the sponsor's last update on 23 Sep 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Panorama of the endometrium (time frame: Menstrual cramps 24 hours, the seventh day of menstruation, LH peak, 72 hours after the peak, the 21st day of menstruation, the 28th day of menstruation). 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 23 Sep 2021.