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Predictive Value of New AMH Test Method for Ovarian Response

NCT04639505 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 454

Last updated 2022-01-13

No results posted yet for this study

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

Interventions

DIAGNOSTIC_TEST

ELISA

ELISA kit detecting the serum AMH level

DIAGNOSTIC_TEST

Chemiluminescence

CLIA method detecting the serum AMH level

Sponsors & Collaborators

  • Reproductive & Genetic Hospital of CITIC-Xiangya

    lead OTHER

Principal Investigators

  • Fei Gong, PhD · Reproductive & Genetic Hospital of CITIC-Xiangya

Eligibility

Min Age
20 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-15
Primary Completion
2021-06-03
Completion
2021-09-30

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04639505 on ClinicalTrials.gov