Predictive Value of New AMH Test Method for Ovarian Response

Overview

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.

Full Title of Study: “Predictive Value of New AMH Test Method for Ovarian Response in Patients With IVF/ICSI”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: March 31, 2021

Interventions

  • Diagnostic Test: ELISA
    • ELISA kit detecting the serum AMH level
  • Diagnostic Test: Chemiluminescence
    • CLIA method detecting the serum AMH level

Arms, Groups and Cohorts

  • ELISA
    • ELISA kit detecting the serum AMH level
  • Chemiluminescence
    • CLIA method detecting the serum AMH level

Clinical Trial Outcome Measures

Primary Measures

  • the AMH(CLIA) cutoff value of low and high ovarian response
    • Time Frame: 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 Measures

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

Participating in This Clinical Trial

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; – FET cycle; – cancer patients.
  • Gender Eligibility: Female

    Minimum Age: 20 Years

    Maximum Age: 45 Years

    Investigator Details

    • Lead Sponsor
      • Reproductive & Genetic Hospital of CITIC-Xiangya
    • Provider of Information About this Clinical Study
      • Sponsor

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