NCT03689101

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
148

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 21, 2016

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

September 21, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 28, 2018

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 2, 2019

Completed
Last Updated

January 11, 2022

Status Verified

January 1, 2022

Enrollment Period

2.6 years

First QC Date

September 21, 2018

Last Update Submit

January 9, 2022

Conditions

Infertility

Outcome Measures

Primary Outcomes (2)

  • CD138 counting

    7 days after LH surge (LH+7)

  • clinical pregnancy rate

    about 28 days after embryo transfer

Study Arms (1)

Endometrial biopsies

EXPERIMENTAL

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

Procedure: Endometrial biopsies

Interventions

Endometrial biopsiesPROCEDURE

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

Endometrial biopsies

Eligibility Criteria

Age20 Years - 38 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Reproductive & Genetic Hospital of CITIC-XIANGYA

Changsha, Hunan, 410000, China

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Fei Gong, doctor

    Reproductive & Genetic Hospital of CITIC-Xiangya

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 21, 2018

First Posted

September 28, 2018

Study Start

March 21, 2016

Primary Completion

November 1, 2018

Study Completion

February 2, 2019

Last Updated

January 11, 2022

Record last verified: 2022-01

Locations

CN(1)