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The Relationship Between CD138 Count of Endometrium and Reproductive Outcome

Primary Purpose

Infertility

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Endometrial biopsies
Sponsored by
Reproductive & Genetic Hospital of CITIC-Xiangya
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Infertility

Eligibility Criteria

20 Years - 38 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • age between20 and 38 years;
  • regular menstrual cycles;
  • body mass index (BMI) ranged from 18 to 25

Exclusion Criteria:

  • uterine abnormalities;
  • intrauterine adhesions（moderate - severe）, advanced endometriosis, adenomyosis, untreated hydrosalpinx, uterine fibroids (submucosal fibroids, nonmucosal fibroids >4.0 cm and/or endometrial pressure)

Sites / Locations

  • Reproductive & Genetic Hospital of CITIC-XIANGYA

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Endometrial biopsies

Arm Description

Endometrial biopsy was performed precisely 7 days after LH surge (LH+7) to count endometrial CD138.

Outcomes

Primary Outcome Measures

CD138 counting
clinical pregnancy rate

Secondary Outcome Measures

Full Information

First Posted
September 21, 2018
Last Updated
January 9, 2022
Sponsor
Reproductive & Genetic Hospital of CITIC-Xiangya
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1. Study Identification

Unique Protocol Identification Number
NCT03689101
Brief Title
The Relationship Between CD138 Count of Endometrium and Reproductive Outcome
Official Title
To Explore the Relationship Between Endometrial CD138 Count and Pregnancy Outcome Following Frozen Embryo Transfer in Natural Cycles
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
March 21, 2016 (Actual)
Primary Completion Date
November 1, 2018 (Actual)
Study Completion Date
February 2, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Reproductive & Genetic Hospital of CITIC-Xiangya

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
It's well known, endometritis affects reproductive outcomes. Though CD138 counting as one new diagnosis measure for endometritis, diagnostic criterion of this measure isn't consistent. And if the CD138 counting is correlation to the outcome of reproductive is not clear. Firstly, This study aims to explore the relationship between endometrial CD138 count and pregnancy outcome following frozen embryo transfer in natural cycles. Secondly , the investigators want to find a cut-off value which is related to reproduction outcome.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
148 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Endometrial biopsies
Arm Type
Experimental
Arm Description
Endometrial biopsy was performed precisely 7 days after LH surge (LH+7) to count endometrial CD138.
Intervention Type
Procedure
Intervention Name(s)
Endometrial biopsies
Intervention Description
Endometrial biopsy was performed precisely 7 days after LH surge (LH+7)
Primary Outcome Measure Information:
Title
CD138 counting
Time Frame
7 days after LH surge (LH+7)
Title
clinical pregnancy rate
Time Frame
about 28 days after embryo transfer

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
38 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: age between20 and 38 years; regular menstrual cycles; body mass index (BMI) ranged from 18 to 25 Exclusion Criteria: uterine abnormalities; intrauterine adhesions（moderate - severe）, advanced endometriosis, adenomyosis, untreated hydrosalpinx, uterine fibroids (submucosal fibroids, nonmucosal fibroids >4.0 cm and/or endometrial pressure)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fei Gong, doctor
Organizational Affiliation
Reproductive & Genetic Hospital of CITIC-Xiangya
Official's Role
Principal Investigator
Facility Information:
Facility Name
Reproductive & Genetic Hospital of CITIC-XIANGYA
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410000
Country
China

12. IPD Sharing Statement

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The Relationship Between CD138 Count of Endometrium and Reproductive Outcome

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