Panoramic Presentation and Tolerance Mechanism of Human Endometrium Based on Tiangui Theory

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 Overview

• Status: Completed
• Conditions: Endometrium; Senility
• Intervention / Treatment: Procedure: Endometrial biopsy

• Study Type: Observational
• Enrollment (Actual): 55

Contacts and Locations

Study Locations

• China
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150040
      • Department of Obstetrics and Gynecology,First Affliated Hospital,Heilongjiang University of Chinese Medicine .

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 49 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

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.

Description

Inclusion criteria:

1. The subject's infertility factors are only male factors and/or fallopian tube factors;
2. 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);
3. Body mass index (weight/height square)=23～25kg/m2;
4. 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);
5. Women with a history of pregnancy are preferred;
6. Asexual life during the study period;
7. No IUD is placed in the uterine cavity;
8. Volunteer to participate in the experiment and sign the informed consent form.

Exclusion criteria:

1. Women who have a history of miscarriage;
2. Women during pregnancy and breastfeeding;
3. Mentally ill;
4. Those who have had oral contraceptives or hormonal drugs in the past three months;
5. Combined with serious primary diseases such as cardiovascular, cerebrovascular, liver, kidney and hematopoietic system;
6. Subjects who have participated in other drug clinical trials within six months;
7. Those who have poor compliance and the investigator thinks it is inappropriate to participate in this clinical trial.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
21 years old group	Procedure: Endometrial biopsy; 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.
28 years old group	Procedure: Endometrial biopsy; 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.
35 years old group	Procedure: Endometrial biopsy; 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.
42 years old group	Procedure: Endometrial biopsy; 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.
49 years old group	Procedure: Endometrial biopsy; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Panorama of the endometrium	Discovery of inner membrane receptive proteins and pathways	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

Collaborators and Investigators

• Sponsor: Heilongjiang University of Chinese Medicine

Study record dates

Study Major Dates

• Study Start (Actual): July 8, 2020
• Primary Completion (Actual): March 5, 2021
• Study Completion (Actual): September 5, 2021

Study Registration Dates

• First Submitted: April 6, 2021
• First Submitted That Met QC Criteria: April 23, 2021
• First Posted (Actual): April 26, 2021

Study Record Updates

• Last Update Posted (Actual): September 23, 2021
• Last Update Submitted That Met QC Criteria: September 22, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: MOM

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No