The Relationship Between CD138 Count of Endometrium and Reproductive Outcome

Infertility Clinical Trial

Official title:

To Explore the Relationship Between Endometrial CD138 Count and Pregnancy Outcome Following Frozen Embryo Transfer in Natural Cycles

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03689101
• Other study ID #: P2018009
• Status: Completed
• Phase: N/A
• Start date: March 21, 2016
• Est. completion date: February 2, 2019

Study information

• Verified date: January 2022
• Source: Reproductive & Genetic Hospital of CITIC-Xiangya
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 148
• Est. completion date: February 2, 2019
• Est. primary completion date: November 1, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 38 Years

Eligibility

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)

Related Conditions & MeSH terms

• Infertility

Intervention

Procedure:
• Endometrial biopsies
Endometrial biopsy was performed precisely 7 days after LH surge (LH+7)

Locations

Country	Name	City	State
China	Reproductive & Genetic Hospital of CITIC-XIANGYA	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Reproductive & Genetic Hospital of CITIC-Xiangya

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CD138 counting		7 days after LH surge (LH+7)
Primary	clinical pregnancy rate		about 28 days after embryo transfer