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

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.

Study Overview

• Status: Completed
• Conditions: Infertility; AMH
• Intervention / Treatment: Diagnostic test: ELISA; Diagnostic test: Chemiluminescence

• Study Type: Observational
• Enrollment (Actual): 454

Contacts and Locations

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China, 410008
      • Reproductive & Genetic hospital Of CITIC-Xiangya

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

infertility females

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ELISA; ELISA kit detecting the serum AMH level	Diagnostic test: ELISA; ELISA kit detecting the serum AMH level; Other Names: experimental group
Chemiluminescence; CLIA method detecting the serum AMH level	Diagnostic test: Chemiluminescence; CLIA method detecting the serum AMH level; Other Names: control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Reproductive & Genetic Hospital of CITIC-Xiangya
• Investigators: Principal Investigator: Fei Gong, PhD, Reproductive & Genetic hospital Of CITIC-Xiangya

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2020
• Primary Completion (Actual): June 3, 2021
• Study Completion (Actual): September 30, 2021

Study Registration Dates

• First Submitted: November 11, 2020
• First Submitted That Met QC Criteria: November 18, 2020
• First Posted (Actual): November 20, 2020

Study Record Updates

• Last Update Posted (Actual): January 13, 2022
• Last Update Submitted That Met QC Criteria: January 11, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infertility
• Other Study ID Numbers: P2020004

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No