Predictive Value of New AMH Test Method for Ovarian Response

Completed

• Conditions: AMH; Infertility
• Interventions: Diagnostic Test: ELISA; Diagnostic Test: Chemiluminescence

• Registration Number: NCT04639505
• Lead Sponsor: Reproductive & Genetic Hospital of CITIC-Xiangya

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-11-11
• Study Start: 2020-11-15
• Study First Submitted QC: 2020-11-18
• Study First Posted: 2020-11-20
• Primary Completion: 2021-06-03
• Study Completion: 2021-09-30
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-11
• Last Update Posted: 2022-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 454

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ELISA	ELISA	ELISA kit detecting the serum AMH level
Chemiluminescence	Chemiluminescence	CLIA method detecting the serum AMH level

Primary Outcome Measures

Name	Time	Method
the AMH（CLIA） cutoff value of low and high ovarian response	the day of oocytes retrieved，about three months after AMH test	the poor ovarian response :the number of retrieved oocyte ≤ 3,the high ovarian response :the number of retrieved oocyte ≥ 15

Secondary Outcome Measures

Name	Time	Method
Number of oocytes retrieved	34-36 hours after hCG trigger，about three months after AMH test	the number of oocytes retrieved after hCG trigger
the serum AMH level	any day of the menstrual cycle, about three months after study starting	anti-muller hormone

Trial Locations

Locations (1)

Reproductive & Genetic Hospital of CITIC-XIANGYA; 🇨🇳 Changsha, Hunan, China