Predictive Value of New AMH Test Method for Ovarian Response

Infertility Clinical Trial

Official title:

Predictive Value of New AMH Test Method for Ovarian Response in Patients With IVF/ICSI

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04639505
• Other study ID #: P2020004
• Status: Completed
• 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
• 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
• 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.

Related Conditions & MeSH terms

• AMH
• Infertility

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