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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04639505
Other study ID # P2020004
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 15, 2020
Est. completion date September 30, 2021

Study information

Verified date January 2022
Source Reproductive & Genetic Hospital of CITIC-Xiangya
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

In China, the incidence of infertility is about 15%, and patients need to use assisted reproductive technology (ART) to obtain pregnancy. It is particularly important to accurately predict the patient's ovarian response before initiating controlled ovulation hyperstimulation (COH). At present, the commonly used AMH detection method is enzyme-linked immunoassay (ELISA), and it has obtained the normal reference range for ovarian response. In recent years, with the development of detection technology, chemiluminescence immunoassay(CLIA) detection reagents have been successively used for the detection of AMH. However, there are few studies on the comparison of these two detection methods. The predictive value of the new method on ovarian response was lack. Therefore, by comparing the two methods of ELISA and CLIA detection of AMH levels in this study, the predictive value of poor ovarian response (the number of retrieved oocyte ≤ 3) and high response (the number of retrieved oocyte ≥ 15) in IVF/ICSI stimulation cycle was analyzed. In order to provide more reference basis for individualized COH, the AMH cutoff value of low and high ovarian response by the new method predicts was analyzed. At the same time, the prediction value of the two methods is compared to determine whether the new CLIA is suitable for clinical application.


Recruitment information / eligibility

Status Completed
Enrollment 454
Est. completion date September 30, 2021
Est. primary completion date June 3, 2021
Accepts healthy volunteers
Gender Female
Age group 20 Years to 45 Years
Eligibility Inclusion Criteria: - The first IVF/ICSI COH cycle; - the causes of infertility :fallopian tube factors and/or male factors; Exclusion Criteria: - Endometriosis; - PCOS; - Adenomyosis; - PGT cycle because of the female chromosome abnormality or genetic abnormality; - FET cycle; - Malignant tumor patient.

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
ELISA
ELISA kit detecting the serum AMH level
Chemiluminescence
CLIA method detecting the serum AMH level

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 the AMH(CLIA) cutoff value of low and high ovarian response the poor ovarian response :the number of retrieved oocyte = 3,the high ovarian response :the number of retrieved oocyte = 15 the day of oocytes retrieved,about three months after AMH test
Secondary Number of oocytes retrieved the number of oocytes retrieved after hCG trigger 34-36 hours after hCG trigger,about three months after AMH test
Secondary the serum AMH level anti-muller hormone any day of the menstrual cycle, about three months after study starting
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