NCT04639505

Predictive Value of New AMH Test Method for Ovarian Response

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 454 (actual)
• Sponsor: Reproductive & Genetic Hospital of CITIC-Xiangya · Academic / Other
• Sex: Female
• Age: 20 Years – 45 Years
• Healthy volunteers: —

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.

Conditions

• Infertility
• AMH

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	ELISA	ELISA kit detecting the serum AMH level
DIAGNOSTIC_TEST	Chemiluminescence	CLIA method detecting the serum AMH level

Timeline

• Start date: 2020-11-15
• Primary completion: 2021-06-03
• Completion: 2021-09-30
• First posted: 2020-11-20
• Last updated: 2022-01-13

Locations

1 site across 1 country: China