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The Relationship Between CD138 Count of Endometrium and Reproductive Outcome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03689101
Recruitment Status : Completed
First Posted : September 28, 2018
Last Update Posted : January 11, 2022
Sponsor:
Information provided by (Responsible Party):
Reproductive & Genetic Hospital of CITIC-Xiangya

Study Description
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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.


Condition or disease Intervention/treatment Phase
Infertility Procedure: Endometrial biopsies Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 148 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: To Explore the Relationship Between Endometrial CD138 Count and Pregnancy Outcome Following Frozen Embryo Transfer in Natural Cycles
Actual Study Start Date : March 21, 2016
Actual Primary Completion Date : November 1, 2018
Actual Study Completion Date : February 2, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy Pregnancy

Arms and Interventions
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Arm Intervention/treatment
Experimental: Endometrial biopsies
Endometrial biopsy was performed precisely 7 days after LH surge (LH+7) to count endometrial CD138.
 Procedure: Endometrial biopsies
Endometrial biopsy was performed precisely 7 days after LH surge (LH+7)


Outcome Measures
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Primary Outcome Measures :
  1. CD138 counting [ Time Frame: 7 days after LH surge (LH+7) ]
  2. clinical pregnancy rate [ Time Frame: about 28 days after embryo transfer ]

Eligibility Criteria
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Ages Eligible for Study:   20 Years to 38 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03689101


Locations
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China, Hunan
Reproductive & Genetic Hospital of CITIC-XIANGYA
Changsha, Hunan, China, 410000
Sponsors and Collaborators
Reproductive & Genetic Hospital of CITIC-Xiangya
Investigators
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Principal Investigator: Fei Gong, doctor Reproductive & Genetic Hospital of CITIC-Xiangya
More Information
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Responsible Party: Reproductive & Genetic Hospital of CITIC-Xiangya
ClinicalTrials.gov Identifier: NCT03689101    
Other Study ID Numbers: P2018009
First Posted: September 28, 2018    Key Record Dates
Last Update Posted: January 11, 2022
Last Verified: January 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infertility