The Relationship Between CD138 Count of Endometrium and Reproductive Outcome

NCT ID: NCT03689101

Last Updated: 2022-01-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

148 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-21

Study Completion Date

2019-02-02

Brief Summary

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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.

Detailed Description

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Conditions

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Infertility

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Endometrial biopsies

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

Group Type EXPERIMENTAL

Endometrial biopsies

Intervention Type PROCEDURE

Endometrial biopsy was performed precisely 7 days after LH surge (LH+7)

Interventions

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Endometrial biopsies

Endometrial biopsy was performed precisely 7 days after LH surge (LH+7)

Intervention Type PROCEDURE

Eligibility Criteria

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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)
Minimum Eligible Age

20 Years

Maximum Eligible Age

38 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Reproductive & Genetic Hospital of CITIC-Xiangya

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Fei Gong, doctor

Role: PRINCIPAL_INVESTIGATOR

Reproductive & Genetic Hospital of CITIC-Xiangya

Locations

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Reproductive & Genetic Hospital of CITIC-XIANGYA

Changsha, Hunan, China

Site Status

Countries

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China

Other Identifiers

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P2018009

Identifier Type: -

Identifier Source: org_study_id

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