Predictive Value of New AMH Test Method for Ovarian Response

Reproductive & Genetic Hospital of CITIC-Xiangya

Status: Completed

Conditions: AMH; Infertility

Treatments: Diagnostic Test: ELISA; Diagnostic Test: Chemiluminescence

Study type: Observational

Funder types: Other

Identifiers

NCT04639505

P2020004

Details and patient eligibility

About

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.

Enrollment: 454 patients

Sex: Female

Ages: 20 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

454 participants in 2 patient groups

ELISA

Description:

ELISA kit detecting the serum AMH level

Treatment:

Diagnostic Test: ELISA

Chemiluminescence

Description:

CLIA method detecting the serum AMH level

Treatment:

Diagnostic Test: Chemiluminescence